Stability Indicating RP-HPLC Method For Combined Dosage Form

A simple, rapid, accurate, sensitive, precise, and isocratic RP- HPLC method was develop for analysis of Nebivolol Hydrochloride and Indapamide in combined tablet dosage form. The best separation was achieved by C-18 reversed phase column (250 mm x 4.6 mm, 5mim particle) with 50 mM Potassium dihydrogen phosphate, pH 3.5 adjusted with ortho phosphoric acid, acetonitrile and triethylamine in ratio (30:70:2 v/v) as mobile phase. Flow rate was set 1 ml/min and detection was carried out at 254 nm. Retention time of Nebivolol Hydrochloride and Indapamide was found to be 3.407 min. and 5.470 min. respectively. The Method has been validated for the combination with parameters like linearity, accuracy and precision and rubustness. Linear response for Nebivolol Hydrochloride and Indapamide were in the range of 50-150 mig/ml and 15-45 mig/ml respectively. The Percentage recoveries obtained for Nebivolol Hydrochloride and Indapamide were found to be 99.87 ± 0.20 and 99.93 ± 0.187 respectively. The study further extended to develop stability indicating method where acid, base, oxidation and thermal degradation was performed.

Autorentext

Imran A. Chaki, Máster en Farmacia, Garantía de Calidad Farmacéutica por la Universidad Tecnológica de Gujarat. Investigador asociado en Quantys Clinical Private Limited en el Departamento de Garantía de Calidad.