18 resultados para Medicamentos de Controle Especial

em Universidade Federal do Rio Grande do Norte(UFRN)


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The concern with issues related to consumer protection has emerged in North America and then spread throughout the world. In Brazil, consumer‟s rights and interests only gained greater importance after their consolidation in the Constitution of 1988 and the enactment of the 8078/90 Law (Consumer‟s Protection and Defense Code), which established the consumerist microsystem. The understanding of the legal relationship of consumption concept is necessarily connected to knowledge of the elements that compose it. Among these, we can find the consumer and the provider (subjective elements), the product or service (objective elements), and the consumer‟s condition as final receiver of the consumption object (finalistic element). In order to elucidate the configuration of consumer protection before advertising communication, this work will analyze the advertising through the prism of consumerist laws, conceptualizing it and presenting a differentiation of it in relation to practices such as marketing, offer and commercial communication as well as examining its several kinds of manifestation, focusing mainly the ones categorized as misleading or unfair advertising. All kinds of advertising communication against the consumerist microsystem are subject to judicial control exercised by the State. Besides individual protection possibilities, this state-owned control can be collectively exercised as a result of the utilization of public civil action and popular action. Some specific categories of advertising (smoking products, alcoholic beverages, pesticides, medicines and therapies) are still subject to a set of particular restraints provided by the 9294/96 Law, which enables the performance of a special control in relation to them. In addition to state control, there is also a system of advertising communication self-regulation, which develops itself through the actions of the National Council of Advertising Self-Regulation that are based mainly on the laws established by the Brazilian Code of Advertising Self-Regulation and its annexes. However, this system of advertising self-regulation still has some deficiencies that hinder its effectiveness

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The Information Technology (IT) is increasing his applicability to business, both private and public companies. It is necessary the adequate use of the new technologies and get cooperation and technology acceptance of the system. People tend to resist to the changes, contributing so that the technology is rejected or even it is not recognized as promoting of the changes. This study is relevant and aim to evaluate the impacts of new technologies, considering their users as fundamental factors in the change process. The survey analyzed the advantages and the barriers of the system use in three federal special judicial of Rio Grande do Norte, with data collected in May of 2007, through the application of questionnaires to thirty eight users of the virtual system CRETA. The users' perception was evaluated, under the optics of five variables: efficiency, image, agility, ease of use and quality. Starting from the obtained results, it was evidenced that the implementation of the system felt accordingly the expected and it reached the objectives intended that were: the velocity and efficiency in the path of the lawsuits, larger productivity, resulting in a better quality of the final work introduced to the citizen and proportionate an improvement in the organizational image of the judiciary power

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Compounded medicines have been reported by the ANVISA due to decreased of the therapeutic response or toxicity of these formulations. The aim of this work was to investigate the physicochemical quality control among naproxen sodium oral suspensions 25 mg/mL obtained from six compounding pharmacies (A, B, C, D, E and F) and the manufactured suspension (R). In the quality control test, the tests of pH, content, homogeneity, volume and physical and organoleptic characteristics were performed according to the Brazilian Pharmacopoeia. The analytical method for determination of naproxen in suspensions was validate. This method showed excellent precision, accuracy, linearity and specificity. In the content test the suspensions B, C and E showed lower value and the F suspension showed a high value of the content. The products C and E were disapproved in the description of the physical and organoleptic characteristics test. In the pH test, three suspensions were outside specifications (C, E and F). Only the products R, A and D showed satisfactory results in these tests and therefore they were approved for relative bioavailability test. The R, A and D suspensions were orally administered to Wistar rats and the blood samples were taken at time intervals of 10, 20, 40, 60 min, 3, 4, 6, 24 and 48 h. The plasma samples were immediately stored at 80 ºC until analysis of HPLC. The bioanalytical method validation showed specificity, linearity (R2 0.9987), precision, accuracy, good recovery and stability. The chromatographic conditions were: flow rate of 1.2 mL.min-1 with a mobile phase of acetonitrile : sodium phosphate buffer pH 4.0 (50:50, v/v) at 280 nm, using a C18 column. The confidence interval of 90% for the Cmax and AUCt ratio was within the range of 80 - 125% proposed by the FDA. Only one suspension, obtained from the compounding pharmacy D, was considered bioequivalent to the rate of absorption under the conditions proposed by this study. Thus, the results indicate the need for strict supervision from the relevant authorities to ensure the patient safety and the quality of compounded drugs by pharmacies

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INTRODUCTION: Drug advertisement stimulates self-medication and irrational use of medicines, especially when it starts to interfere in the prescription. Monitoring advertisements, as well as the observation of its influence on health professionals, prescriptions become necessary because of this public health problem. OBJECTIVE: The aim of this work was to analyze drug advertisements directed to gynecologists and/or obstetricians doctors relating them to the current legislation as well as its influence on prescription. METHODOLOGY: The sample was composed of drug advertisements divulged to the gynecologists and / or obstetricians doctors and was analyzed according to RDC96/2008. To evaluate the influence of advertisement on prescription, a questionnaire was administered to gynecologists / obstetricians doctors and prescriptions of a public maternity were also evaluated. RESULTS AND CONCLUSION: Concerning the advertisements analyzed, 48% complied fully with current legislation and 52% of the advertisements analyzed were in accordance to the RDC No. 96/2008 in most of the items evaluated. The doctors interviewed are used to receive the visits of propagandists, even in the public service, receiving gifts offered by the industry and believe that medicine advertisement tries to influence prescribing. Many of them use the material provided by the propagandist as a source for their prescription, although they present a critical view about them information. The use of trade name / mark on the prescription is a common practice among the doctors interviewed, even in the public service, suggesting there is an influence of medicine advertisement on the prescription

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It is a fact that the fundamental rights of citizens are being recognized and guaranteed by the state over time, regardless of the belief that if these rights has always been part of the heritage of subjective individuals, or whether they will be aggregated during the course of human history. In that, emerged the rights of freedom of men and, subsequently, the rights to create a situation of equality between the humans, the so-called social rights. In turn, as these rights known as social, to be implemented, need a positive action by the state, more precisely by the state power whose function is to manage public money and create policies for implementation of fundamental rights. Given this, pay attention to the right to health, was created the Programa de Medicamentos de Dispensação Excepcional, which aims to provide high-cost medicines to citizens Brazilian carriers of serious diseases, such as Alzheimer's and Mal Hepatitis C. Also on the program, it provides a way which will be mandatory that the drugs will be offered in such situations, and does not include a means of updating the list predicted able to monitor the progress of medicine that have been in the interest of the program. Given that, at present it is necessary to mention the recognition of another fundamental right: the right to development, which is the right of access to positive actions being implemented by the State, which are nothing more than public policy, gender which the Programa de Medicamentos de Dispensação Excepcional is kind. Thus, through the search in legislation and doctrine in relation to the theme, this work has the aim to examine the extent of the state to provide exceptional dispensing of medicines. Specifically, if the State in attention to the right to development and the implementation of the right to health, can really list exhaustively the drugs to be provided by the State, and what are the elements guiding this choice and how to control the same

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In Brazil, social rights have always been considered secondary legal categories, whose implementation could wait for the pending of political decisions. At the end of the Second World War, International Law emphasizes the protection of human beings, raising his dignity as a legal pillar of the legal orders and one of the main foundations of Constitutions. At the post-positivism Constitutionalism, the realization of social rights receives special attention with the assumption of supremacy and normativity of the Constitutions, while the judiciary participates in the realization of democracy, not only as applicator of laws, but also as the guardian of constitutionality of the acts and administrative omissions, creatively contributing to the constitutional achievement, filling gaps and normative state omissions. In this aspect, the supply of medicines, whose costs can not be supported by the individual, keep a close connection with the right to life, health and dignity of the human being, as the subject of numerous lawsuits directed against the Public Administration. Such phenomenon has caused intense debate regarding judicial activism and legitimacy of these decisions, particularly on the need to define what are the limits and possibilities considering the principle of separation of powers and the principle of reserve of the possible; bieng this the problematic developed in this research. Thus, this research aims to verify the legitimacy of judicial decisions that determines to the Public Administration the compulsory providing of medicine to those who can not afford the cost of their treatment, as well as, contribute to the dogmatic constructions of parameters to be observed by judicial interference. Regarding the methodology, this research has an investigative and descriptive caracter and an theoretical approach based on bibliographical data collection (judicial and doutrine decisions) that received qualitative treatment and dialectical approach. As a result, it is known that the judicial decision that determines the supply of medicines to those individuals who can not afford them with their own resources is legitimate and complies with the democratic principle, not violating the principle of separation of powers and the reserve of the possible, since the judicial decison is not stripped with an uniform and reasonable criteria, failing to contain high burden of subjectivism and witch signifies a possible exacerbation of functions by the judiciary, suffering, in this case, of requirement of legal certainty. It is concluded that the Court decision that determines the government the providing of medicine to those who can not afford the cost of treatment should be based on parameters such as: the protection of human dignity and the minimum existencial principle, the inafastable jurisdiction principle; compliance critique of the possible reserve principle; subsidiarity of judicial intervention; proportionality (quantitative and qualitative) in the content of the decision; the questioning about the reasons for non-delivery of the drug through administrative via; and, finally, the attention not to turn the judiciary into a mere production factor of the pharmaceutical industry, contributing to the cartelization of the right to health

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Tuberculosis is a disease of great impact on the world context today. In Brazil, the disease management was directed to the Primary Health Care, due to the determination of the Ministry of Health to decentralize health actions for primary care. Thus, since the actions of diagnosis, treatment and control of the disease should happen in this context, however, there are still many barriers that may hinder the realization of these determinations. This study aims to analyze the development of tuberculosis control activities conducted in the services of primary health care from the patient's vision. This is a descriptive, cross-sectional and quantitative study. The population consists of 517 tuberculosis patients treated in units of Primary Health Care in the city of Natal-RN; the sample consists of 93 TB patients. The collect instrument is structured, based in The Primary Care Assessment Tool (PCAT), validated in Brazil and adapted to assess attention to TB in Brazil, with modifications. This instrument was divided into blocks: the first one describes the socio-demographic information of patients with TB and the second one describes the health services working in control, diagnosis and treatment of TB, and includes issues related to the dimensions of primary care: access, bond, services, coordination of care, guidance to the community and family focus. For quantitative analysis, were built indicators for each item of the instrument. The response patterns are followed according to the Likert scale, which was assigned a value between one and five meant that the degree of preference relation (or agreement) of the statements. Values between 1 and 3 were considered unsatisfactory for the indicator, between 3 and less than 4, regular, and between 4 and 5, satisfactory. The results indicate that 62.37% of patients are male, 27.96% aged 41 to 50 years old, and 34.41% unemployed, with low education and low family income. It was found that the reference hospital services are the front door to the patient (59.14%), and are also the local diagnosis of the disease (72.04%). On access, the conditions satisfactory found are: the number of times the patients need to pick up the health care issue, the marking and the facility to get a consultancy in the HS, assistance provided without harm to the individual's attendance labor and facilities related to the proximity between the residence and services; were considered unsatisfactory conditions related to travel to the HS, and on hours and days of operation of services. As for the cast of services were satisfactory and regular actions related to the request for examination to become viable in the first HS, the availability of pot to perform smear and medicines for the treatment, as well as consultations control and receiving information about the disease and the treatment performed; it is considered unsatisfactory the performance of the home care for patients with TB by the HS that acts as a front door, for implementation of the Directly Observed Treatment (DOT), home visits during treatment, the provision of transportation allowance to the patient and the existence of groups for TB patients. Regarding the coordination of care, resulted in regular the action of referring the patient to other HS to obtain examinations, and as unsatisfactory referral to obtain medications. The relationship bond between patient and health team were considered satisfactory in the majority or regular. As for the family and community focus, is satisfactory only the indicator relating to questions from professionals to the patient about the existence of respiratory symptoms in the family. It is considered that there is need for greater commitment from government entities to the incentives required to TB control, as well as the availability of necessary inputs and training of human resources working in the PHC in the ongoing quest to strengthen primary care, as a place of broader host needs to contact the user with the actions and health professionals. It is recommended the adoption of management mechanisms possible to expand the capacity of the health PHC, promoting the service delivery to the user and ensuring attention to population health.

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This Master Thesis presents a case study on the use of Statistical Process Control (SPC) at the Núcleo de Pesquisas em Alimentos e Medicamentos (NUPLAM). The SPC basic tools have been applied in the process of the tuberculostáticos drugs encapsulation, primarily concerning the objective to choose, between two speeds, which one is the best one to perform the tuberculostatics encapsulation. Later on, with the company effectively operating, the SPC was applied intending to know the variability of the process and, through the tracking of the process itself, to arrive at an estimated limit for the control of future lots of tuberculostatics of equal dosage. As special causes were detected acting in the process, a cause-and-effect diagram was built in order to try to discover, in each factor that composes the productive process, the possible causes of variation of the capsules average weight. The hypotheses raised will be able to serve as a base for deepened the study to eliminate or reduce these interferences in the process. Also a study on the capacity of the process to attend the specifications was carried out, and this study has shown the process´s inaptitude to take care of them. However, on the side of NUPLAM exists a real yearning to implant the SPC and consequently to improve the existing quality already present on its medicines

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This work describes the study and the implementation of the vector speed control for a three-phase Bearingless induction machine with divided winding of 4 poles and 1,1 kW using the neural rotor flux estimation. The vector speed control operates together with the radial positioning controllers and with the winding currents controllers of the stator phases. For the radial positioning, the forces controlled by the internal machine magnetic fields are used. For the radial forces optimization , a special rotor winding with independent circuits which allows a low rotational torque influence was used. The neural flux estimation applied to the vector speed controls has the objective of compensating the parameter dependences of the conventional estimators in relation to the parameter machine s variations due to the temperature increases or due to the rotor magnetic saturation. The implemented control system allows a direct comparison between the respective responses of the speed and radial positioning controllers to the machine oriented by the neural rotor flux estimator in relation to the conventional flux estimator. All the system control is executed by a program developed in the ANSI C language. The DSP resources used by the system are: the Analog/Digital channels converters, the PWM outputs and the parallel and RS-232 serial interfaces, which are responsible, respectively, by the DSP programming and the data capture through the supervisory system

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In the last decade, the renewable energy sources have present a major propulsion in the world due to several factors: political, environmental, financial and others. Within this context, we have in particular the energy obtained through wind, wind energy - that has highlighted with rapid growth in recent years, including in Brazil, mostly in the Northeast, due to it s benefit-cost between the clean energies. In this context, we propose to compare the variable structure adaptive pole placement control (VS-APPC) with a traditional control technique proportional integral controller (PI), applied to set the control of machine side in a conversion system using a wind generator based on Double-Fed Induction Generator (DFIG). Robustness and performance tests were carried out to the uncertainties of the internal parameters of the machine and variations of speed reference.

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This study aimed to apply, thermogravimetriy /derivative Thermogravimetriy (TG/DTG), differential scanning calorimetry (DSC), Differential Thermal Analysis (DTA), to conduct a comparative study on drug reference, generic and whose active principles are similar captopril hydrochlorothiazide, ampicillin, paracetamol, aspirin and mebendazole sold in local pharmacies. Samples of the active ingredients and dosage forms were also characterized by absorption infrared spectroscopy (IR), X-ray diffraction (XRD) and microscopy scanning electron (SEM). The TG / DTG curves showed a general similarity in the thermal behavior of the samples, but also showed the influence of excipients on the thermal stability. The DSC curve of the generic base hydrochlorothiazide showed no peak on the fusion of the drug due to interference of lactose as a diluent, which causes interaction with the active principle causing their degradation before the merger. The DSC curves of the drugs consisting of paracetamol showed reproducibility at the melting point of the active and the other thermal events. The DSC result of binary mixtures involving captopril / magnesium stearate and mebendazole/magnesium stearate showed possible interactions or incompatibilities evidenced by the displacement of the melting point of both drugs. The other mixtures showed no change. The infrared spectra presented were very similar, indicating the presence of functional groups characteristic of the constituents of the samples. The X-ray diffraction showed peaks indicative of crystalline structure of the active ingredients as well as some of the ingredients in the formulation of the drug and the micrographs indicate a general heterogeneity in the size distribution of particles in the samples

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the institutionalized elderly presents for being more fragile a lot of body balance s changes, which can induce falls and health frailty. One of the consequences of it is the appearance of dizziness, vestibular or not. This study aims to identify the risk factors related to dizziness in institutionalized elderly, with and without vestibular disorders, in the city of Natal-RN. Method: a case-control study realized in 12 regulated by Health Surveillance Long Term Care Institutions for the elderly in Natal-RN. Elected seniors with good cognitive level and able to walk, totaling 115 individuals, and of these, 102 were selected according to the presence of dizziness in the last year (n = 51) and their controls (n = 51), paired by sex and age. The 51 elderly patients with dizziness were divided into 3 groups case: case one, for elderly with dizziness and without vestibulopathy (n=38); case two, for elderly with dizziness and vestibulopathy (n=13) and case three, for all the seniors with dizziness, or added to the case 1 case 2 (n=51). The 51 seniors who served as controls were also divided into three groups, according to the number of individuals of each case: control 1, n = 38, control 2, n = 13 control and 3 (sum of 1 control with control 2), n = 51. As possible risk factors were analyzed variables related to characteristics of the institution, to the habits of life of older people and those concerned with the health of the elderly. For statistical analysis, we used the chi-square or Fisher exact test for a significance level of 5% and calculating the association magnitude between variables by measuring the Odds Ratio. Results: as risk factors for dizziness without vestibular disorders were found the presence of hypertension and cardiovascular disease, as well as the presence of three or more disorders for elderly and use of gastric protector drugs. For the elderly group from case two were found no associated risk factor. For elderly patients with dizziness in the case group three, we observed the same risk factors found for the elderly in the case group one, plus the presence of osteoarthritis pathology, which was also significant for this group. Conclusion: dizziness in institutionalized elderly is associated with systemic common diseases in this age group and the vestibulopathy presents itself as pathology on an isolated way, not being possible, with our data, associate it with non-risk factors

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The chaotic behavior has been widely observed in nature, from physical and chemical phenomena to biological systems, present in many engineering applications and found in both simple mechanical oscillators and advanced communication systems. With regard to mechanical systems, the effects of nonlinearities on the dynamic behavior of the system are often of undesirable character, which has motivated the development of compensation strategies. However, it has been recently found that there are situations in which the richness of nonlinear dynamics becomes attractive. Due to their parametric sensitivity, chaotic systems can suffer considerable changes by small variations on the value of their parameters, which is extremely favorable when we want to give greater flexibility to the controlled system. Hence, we analyze in this work the parametric sensitivity of Duffing oscillator, in particular its unstable periodic orbits and Poincar´e section due to changes in nominal value of the parameter that multiplies the cubic term. Since the amount of energy needed to stabilize Unstable Periodic Orbits is minimum, we analyze the control action needed to control and stabilize such orbits which belong to different versions of the Duffing oscillator. For that we will use a smoothed sliding mode controller with an adaptive compensation term based on Fourier series.

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The insomnia disorder is defined as a difficulty initiating or maintaining sleep or waking up earlier than expected unable to return to sleep, followed by a feeling of nonrestorative and poor quality sleep, present for at least three months, with consequences on daytime functioning. Studies have shown that insomnia affects cognitive function, especially executive functions. However, researches that sought to investigate the relationship between primary insomnia and executive functioning were quite inconsistent from a methodological point of view, especially in regard to the variability of the used methods, the heterogeneity of diagnostic criteria for insomnia and the control of sleep altering drugs. In this sense, the present study aimed to investigate the relationship between insomnia and executive functions in adults. The participants were 29 people, from both genders, aged 20-55 years old. Participants were divided into three groups, one composed of 10 people with primary insomnia who used sleep medication (GIM), nine people with primary insomnia who did not use medication (GInM) and 10 healthy people who composed the control group (CG). The research was conducted in two stages. The first one involved a diagnostic evaluation for insomnia disorder through a clinical interview and the application of the following protocols: the Athens Insomnia Scale, the Insomnia Severity Index, Sleep Journal (for 14 days), Pittsburgh Sleep Quality Index (PSQI), the Stanford Sleepiness Test, depression and anxiety Beck inventories, and Lipp’s Iventory of stress symptoms for adults. After this stage, the evaluation of executive functions was performed by applying a battery of neuropsychological tests composed by the following tests: Wisconsin, Stoop Test, Colored trails Test, the Tower of London Test, Iowa Gambling Task (IGT) and WAIS III subtest digit span, which measured selective attention, inhibitory control, cognitive flexibility, planning, problem solving, decision making and working memory, respectively. The results showed that insomniacs (GIM and GInM) showed higher sleep latency, shorter sleep duration and lower sleep efficiency compared to the CG. In regard to the performance in executive functions, no statistically significant difference between groups was observed in the evaluated modalities. However, the data show evidence that, compared to GInM and GC, the performance of GIM was lower on tasks that required quick responses and changes in attention focus. On the other hand, GInM, when compared to GIM and GC, showed a better performance on tasks involving cognitive flexibility. Furthermore, impaired sleep measures were correlated with the worst performance of insomniacs in all components evaluated. In conclusion, people with the insomnia disorder showed a performance similar to healthy people’s in components of the executive functioning. Thus, one can infer that there is a relationship between primary insomnia and executive functions in adults.

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The Benzylpenicillin (PENG) have been as the active ingredient in veterinary medicinal products, to increase productivity, due to its therapeutic properties. However, one of unfortunate quality and used indiscriminately, resulting in residues in foods exposed to human consumption, especially in milk that is essential to the diet of children and the ageing. Thus, it is indispensable to develop new methods able to detect this waste food, at levels that are toxic to human health, in order to contribute to the food security of consumers and collaborate with regulatory agencies in an efficient inspection. In this work, were developed methods for the quality control of veterinary drugs based on Benzylpenicillin (PENG) that are used in livestock production. Additionally, were validated methodologies for identifying and quantifying the antibiotic residues in milk bovine and caprine. For this, the analytical control was performed two steps. At first, the groups of samples of medicinal products I, II, III, IV and V, individually, were characterized by medium infrared spectroscopy (4000 – 600 cm-1). Besides, 37 samples, distributed in these groups, were analyzed by spectroscopy in the ultraviolet and near infrared region (UV VIS NIR) and Ultra Fast Liquid Chromatograph coupled to linear arrangement photodiodes (UFLC-DAD). The results of the characterization indicated similarities, between PENG and reference standard samples, primarily in regions of 1818 to 1724 cm-1 of ν C=O that shows primary amides features of PENG. The method by UFLC-DAD presented R on 0.9991. LOD of 7.384 × 10-4 μg mL-1. LOQ of 2.049 × 10-3 μg mL-1. The analysis shows that 62.16% the samples presented purity ≥ 81.21%. The method by spectroscopy in the UV VIS NIR presented medium error ≤ 8 – 12% between the reference and experimental criteria, indicating is a secure choice for rapid determination of PENG. In the second stage, was acquiring a method for the extraction and isolation of PENG by the addition of buffer McIlvaine, used for precipitation of proteins total, at pH 4.0. The results showed excellent recovery values PENG, being close to 92.05% of samples of bovine milk (method 1). While samples of milk goats (method 2) the recovery of PENG were 95.83%. The methods for UFLC-DAD have been validated in accordance with the maximum residue limit (LMR) of 4 μg Kg-1 standardized by CAC/GL16. Validation of the method 1 indicated R by 0.9975. LOD of 7.246 × 10-4 μg mL-1. LOQ de 2.196 × 10-3 μg mL-1. The application of the method 1 showed that 12% the samples presented concentration of residues of PENG > LMR. The method 2 indicated R by 0.9995. LOD 8.251 × 10-4 μg mL-1. LOQ de 2.5270 × 10-3 μg mL-1. The application of the method showed that 15% of the samples were above the tolerable. The comparative analysis between the methods pointed better validation for LCP samples, because the reduction of the matrix effect, on this account the tcalculs < ttable, caused by the increase of recovery of the PENG. In this mode, all the operations developed to deliver simplicity, speed, selectivity, reduced analysis time and reagent use and toxic solvents, particularly if compared to the established methodologies.