Adjuvant therapy with sodium alendronate for the treatment of experimental periodontitis in rats

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Physico-chemical characterization and analytical development for sodium azumolene, a potential drug designed to fight malignant hyperthermia

Sodium azumolene is a drug designed to fight Malignant Hyperthermia (MH), which is characterized by genetic predisposition and triggered by the use of inhalational anesthetics. This drug is shown as a water-soluble analogue of dantrolene sodium, 30-folds more water soluble, which gives advantages for its emergency use. To our knowledge there is no analytical method for sodium zaumolene raw material or dosage form published so far. The objective of the present investigation was to develop and validate analytical methods to achieve sodium azumolene chemical identification and quantification. The sodium azumolene was characterized regarding its thermal behavior, by differential thermal analysis and thermogravimetric analysis; Visible, UV and infrared absorption. To accurately assess the sodium Azumolene content three different analytical methods (visible and UV spectrophotometry and high performance liquid chromatography) were developed and validated. All methods showed to be linear, accurate, precise and reliable. Azumolene has shown to be equipotent to dantrolene in the treatment and prevention of an MH crisis and the great advantage compared to dantrolene is better water solubility. This study has characterized the sodium azumolene and presents new analytical methods which have not been reported so far.

Development and validation of a rapid turbidimetric assay to determine the potency of ampicillin sodium in powder for solution for injection

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Validation of analytical methodology for quantification of cefazolin sodium by liquid chromatography

A reversed-phase high performance liquid chromatography method was validated for the determination of cefazolin sodium in lyophilized powder for solution for injection to be applied for quality control in pharmaceutical industry. The liquid chromatography method was conducted on a Zorbax Eclipse Plus C18 column (250 x 4.6 mm, 5 μm), maintained at room temperature. The mobile phase consisted of purified water: acetonitrile (60: 40 v/v), adjusted to pH 8 with triethylamine. The flow rate was of 0.5 mL min-1 and effluents were monitored at 270 nm. The retention time for cefazolin sodium was 3.6 min. The method proved to be linear (r2 =0.9999) over the concentration range of 30-80 µg mL-1. The selectivity of the method was proven through degradation studies. The method demonstrated satisfactory results for precision, accuracy, limits of detection and quantitation. The robustness of this method was evaluated using the Plackett–Burman fractional factorial experimental design with a matrix of 15 experiments and the statistical treatment proposed by Youden and Steiner. Finally, the proposed method could be also an advantageous option for the analysis of cefazolin sodium, contributing to improve the quality control and to assure the therapeutic efficacy

Development and validation of an economic, environmental friendly and stability-indicating analytical method for determination of ampicillin sodium for injection by RP-HPLC

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Development of an innovative, ecological and stability-indicating analytical method for semiquantitative analysis of ampicillin sodium for injection by thin layer chromatography (TLC)

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Quantitative methods for the identification of cefuroxime sodium

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Development and validation of the quantitative analysis of cefuroxime sodium in powder for injection by infrared spectroscopy

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

A critical review of analytical methods for determination of ertapenem sodium

Antimicrobials have unquestionable importance in the control of many diseases; however the constant concern with evolution of resistant microorganisms is increasing. The ertapenem sodium is a β-lactam antibiotic of the carbapenem class, which it has a broader activity spectrum than most other β-lactam antimicrobials, and is more resistant to the enzyme β-lactamase, which is the main mechanism of resistance of many bacteria. The progress of microbial resistance to existing antibiotics is alarming. Thus we need to preserve antimicrobials that still have activity against these pathogens. In this context, the quality control has a key role to ensure the correct dosage, by contributing preventively to minimize the development of resistant microorganisms. Study of the physicochemical characteristics of the drug and the quantification of the content of active substance are of fundamental importance for the pharmaceutical industry to ensure the quality of the product sold. This work presents a literature survey of existing methods for ertapenem sodium quantification which was performed. Ertapenem sodium can be analyzed by many types of assays; however the HPLC is the most used method. This review will examine the published analytical methods reported for determination of ertapenem sodium, in biological fluids and formulations.

Development and validation of a stability-indicative agar diffusion assay to determine the potency of flucloxacillin sodium in capsules

Flucloxacillin sodium (FLU) is a semi-synthetic penicillin active against many gram-positive bacteria such as streptococci and penicilinase-producing staphylococci, including methicillin-susceptible S. aureus. This study describes the development and validation of a microbiological assay, applying the diffusion agar method for the determination of FLU, as well as the evaluation of the ability of the method in determining the stability of FLU in capsules against acidic and basic hydrolysis, photolytic and oxidative degradations, using S. aureus ATCC 25923 as micro-organism test and 3 x 3 parallel line assay design (three doses of the standard and three doses of the sample in each plate), with six plates for each assay, according to the Brazilian Pharmacopoeia. The validation method showed good results including linearity, precision, accuracy, robustness and selectivity. The assay is based on the inhibitory effect of FLU using Staphylococcus aureus ATCC 25923. The results of the assay were treated by analysis of variance (ANOVA) and were found to be linear (r = 0.9997) in the range from 1.5 to 6.0 μg/mL, precise (repeatability: R.S.D. = 1.63 and intermediate precision: R.S.D. = 1.64) and accurate (98.96%). FLU solution (from the capsules) exposed to direct UVC light (254 nm), alkaline and acid hydrolysis and hydrogen peroxide causing oxidation were used to evaluate the specificity of the bioassay. Comparison of bioassay and liquid chromatography by ANOVA showed no difference between methodologies. The results demonstrated the validity of the proposed bioassay, which is a simple and useful alternative methodology for FLU determination in routine quality control.

Development and validation of the quantitative analysis of ampicillin sodium in powder for injection by Fourier-transform infrared spectroscopy (FT-IR)

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Validation of cefazolin sodium by UV-spectrophotometric method

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Methods for qualitative analysis of cefazolin sodium raw material and pharmaceutical product

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)