Résumé
UV Spectrophotometric method was developed and validated for the quantitative determination of Prothionamide in bulk drug and in pharmaceutical formulations. Prothionamide shows the maximum absorbance at 288 nm in phosphate buffer (pH 7.4). Prothiona-mide follows Beer’s law in the concentration range of 4-20 μg/ml (r2 = 0.999). The detection limit (DL) and quantitation limit (QL) were 0.406 and 1.229 μg/ml respectively. Accuracy and precision were found to be satisfactory. The developed methods were validated according to ICH guidelines. All the validation parameters were found to be satisfactory accordance with the standard values. Therefore, the proposed method can be used for routine practice for the determination of Prothionamide in assay of bulk drug and pharmaceutical formulations.
Résumé
ABSTRACT UV Spectrophotometric method was developed and validated for the quantitative determination of Prothionamide in bulk drug and in pharmaceutical formulations. Prothionamide shows the maximum absorbance at 288 nm in phosphate buffer (pH 7.4). Prothiona-mide follows Beer’s law in the concentration range of 4-20 μg/ml (r2 = 0.999). The detection limit (DL) and quantitation limit (QL) were 0.406 and 1.229 μg/ml respectively. Accuracy and precision were found to be satisfactory. The developed methods were validated according to ICH guidelines. All the validation parameters were found to be satisfactory accordance with the standard values. Therefore, the proposed method can be used for routine practice for the determination of Prothionamide in assay of bulk drug and pharmaceutical formulations
Résumé
OBJECTIVE:To establish a method for determination of ionization equilibrium constant of sildenafil using ultraviolet spectrophotometry.METHODS:Methanol solutions of sildenafil with pH values of 2.26,8.56,9.31,9.83 and 12.38 were respectively scanned at the wavelength within the range of 200nm~400nm.The absorbability and pKa value of sildenafil were determined at the selected wavelength of 280,287,290,295 and 297nm respectively.RESULTS:The pKa value of sildenafil was 9.35?0.02.CONCLUSION:The present method is convenient and practicable.