Development and validation of a microbiological agar assay for determination of orbifloxacin in pharmaceutical preparations

Orbifloxacin is a fluoroquinolone with broad-spectrum antimicrobial activity, and belongs to the third generation of quinolones. Regarding the quality control of medicines, a validated microbiological assay for determination of orbifloxacin in pharmaceutical formulations has not as yet been reported. For this purpose, this paper reports the development and validation of a simple, sensitive, accurate and reproducible agar diffusion method to quantify orbifloxacin in tablet formulations. The assay is based on the inhibitory effect of orbifloxacin upon the strain of Staphylococcus aureus ATCC 25923 used as test microorganism. The results were treated statistically by analysis of variance and were found to be linear (r = 0.9992) in the selected range of 16.0-64.0 μg/mL, precise with relative standard deviation (RSD) of repeatability intraday = 2.88%, intermediate precision RSD = 3.33%, and accurate (100.31%). The results demonstrated the validity of the proposed bioassay, which allows reliable orbifloxacin quantitation in pharmaceutical samples and therefore can be used as a useful alternative methodology for the routine quality control of this medicine. © 2011 by the authors; licensee MDPI, Basel, Switzerland.

A simple and environmentally friendly reflectometric method for the rapid quantitative analysis of captopril in pharmaceutical formulations

This paper describes a simple, environmentally friendly and rapid quantitative spot test procedure for the determination of captopril (CPT) in bulk drug and in pharmaceutical formulations by using diffuse reflectance spectroscopy. The proposed method is based on the reflectance measurements of the orange compound (λ max 490 nm) produced by the spot test reaction between CPT and p-chloranil (CL). Under optimal conditions, calibration curves were obtained for CPT by plotting the optical density of the reflectance signal (A R) vs. the log of the mol L -1 concentration, from 6.91×10 -3 to 1.17×10 -1, with a good coefficient of determination (R 2 = 0.9992). The common excipients used as additives in pharmaceuticals do not interfere in the proposed method. The method was applied to determine CPT in commercial pharmaceutical formulations. The results obtained by the proposed method are compared favorably with those obtained by an official procedure at 95% confidence level. The method validation results showed that the sensitivity and selectivity of the methods were adequated for drug monitoring in industrial quality control laboratories. © 2011 Moment Publication.

Static and dynamic impacts of MERCOSUR: the case of the pharmaceutical sector

Includes bibliography

Report of the ECLAC/CCST workshop on the pharmaceutical sector in the Caribbean, 14-19 March 1986, Havana, Cuba

Presenta las recomendaciones de la reunion en la que se trato el rol del CCCT en la promocion del intercambio de informacion, el estrechamiento de la asistencia tecnica entre los paises de la region, y el de aunar los esfuerzos de los cientificos en la busqueda de soluciones a los problemas comunes en el sector farmaceutico.

Square-wave voltammetric determination of rutin in pharmaceutical formulations using a carbon composite electrode modified with copper (II) phosphate immobilized in polyester resin

Descreve-se um eletrodo de carbono modificado com fosfato de cobre (II) imobilizado em uma resina de poliéster (Cu₃(PO₄)₂-Poly) para a determinação de rutina em amostras farmacêuticas por voltametria de onda quadrada. O eletrodo modificado permite a determinação de rutina em potencial (0.20 V vs Ag / AgCl (3,0 mol L^-1 KCl)) menor que o observado em um eletrodo não modificado. Verificou-se que a corrente de pico foi linear com a concentração de rutina na faixa de 9,9 × 10^-8 a 2,5 × 10^-6 mol L^-1, com um limite de detecção de 1,2 × 10^-8 mol L^-1. A resposta do eletrodo foi estável, sem variação significativa dentro de várias horas de operação contínua. A morfologia da superfície do eletrodo modificado foi caracterizada por microscopia eletrônica de varredura (MEV) e pelo sistema de energia dispersiva de raios-X (EDX). Os resultados obtidos foram precisos e exatos. Ademais, estes resultados estão de acordo com aqueles obtidos pelo método cromatográfico a um nível de confiança de 95%.

Standardized plant extract, method for preparing an extract from plants of the Sclerolobium Genus, cosmetic composition, pharmaceutical composition and use of said extract

Extracts of plants of the Sclerolobium genus are disclosed, as well as methods for preparing same and cosmetic and pharmaceutical formulations containing these extracts. These extracts can be obtained by polar and/or apolar extraction, each fraction containing different anti-oxidants, all of which are useful for topical treatment. Also disclosed is the use of this extract in cosmetic and/or pharmaceutical formulations for topical use.

Validation of analytical methodology for quantification of cefazolin sodium pharmaceutical dosage form by high performance liquid chromatography to be applied for quality control in pharmaceutical industry

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

A simple and portable instrument for determination of captopril in pharmaceutical formulations

Objective: This article describes the application and the performance of a cheap, simple and portable device that can be used for colorimetric quantitative determination of captopril (CPT) in pharmaceutical preparations. Methods: The sensor is a light detector resistor (LDR) placed into a black PTFE cell and coupled to a low cost multimeter (Ohmmeter). The instrument has been tested and is easy and fast to use. The quantitative study is based mainly on reduction of ammonium molybdate by captopril, in the presence of sulphuric acid, producing a green-yellow compound (max 407 nm). The calibration curves were obtained by plotting the electric resistance of the LDR against the CPT concentration on the range of 4.60 x 10-4 to 1.84 x 10-3 mol l-1 with a good coefficient of determination (R2 = 0.9962). Results: Statistical analysis of the obtained results showed no significant difference between the proposed methodology and the official reported method as evident from the t-test and variance ratio at 95% confidence level. Conclusion: The results of this study demonstrate that the instrument can be used for simple, accurate, precise, fast, in situ and low-cost colorimetric analysis of captopril in pharmaceuticals products.

Pharmaceutical care in Brazilian community pharmacies: knowledge and practice

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Development and validation of a simple, rapid and stability-indicating high performance liquid chromatography method for quantification of norfloxacin in a pharmaceutical product

A stability-indication high performance liquid chromatographic method has been developed for the determination of norfloxacin in tablet dosage forms. Optimum separation was achieved in less than 7 minutes using Eclipse Plus Zorbax C18 Agilent, 150 mm×4.6 mm i.d., 5 μm particle size column. The analyte was resolved by using a mobile phase 5% acetic acid aqueous solution and methanol (80:20, v/v) at a flow rate 1.0 ml/min on an isocratic high performance liquid chromatographic system at a wavelength of 277 nm. Linearity, system suitability, precision, sensitivity, selectivity, specific, and robustness were established by International Conference Harmonization guidelines. For stress studies the drug was subjected to photolysis, oxidation, acid, alkaline and neutral conditions. The analytical conditions and the solvent developed provided good resolution within a short analysis time and economic advantages. The proposed method not required sophisticated and expensive instrumentation.

Stability study and degradation kinetics of ceftazidime in pharmaceutical preparations

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

Comparison of high performance liquid chromatography and three titrimetric methods for the determination of ceftazidime in pharmaceutical formulations

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

Thermal analysis and validation of UV and visible spectrophotometric methods for the determination of new antibiotic tigecycline in pharmaceutical product

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