RP-HPLC method development and stability studies of nevirapine in pharmaceutical dosage form

Abstract

A  selective,  specific  and  sensitive  stability-indicating Reverse  phase  high-performance liquid  chromatographic method (RP-HPLC) was developed and validated for the estimation of Nevirapine in pharmaceutical dosage forms. The method was performed on HPLC WATERS equipped with Isocratic with UV-Visible Detector using Develosil ODS HG-5 RP C18 column (15cm × 4.6 mm, 5μm) and Mobile phase used is a mixture of Acetate Buffer (pH=3.9): Acetonitrile (45:55) with a flow rate of 1.0 ml/min. Detection wavelength was 246nm and temperature was Ambient. The percentage relative standard deviation in precision and accuracy studies was found to be less than 2%. The proposed method was validated according to ICH guidelines. Nevirapine was subjected to stress conditions of degradation in aqueous solutions including acidic, alkaline, oxidation, photolysis and thermal degradation and it was found that the drug is highly resistant towards all degradations. The developed method was validated with regard to linearity, accuracy, precision, selectivity and robustness and the method was found to be precise, accurate, linear and specific. As the proposed HPLC method achieved satisfactory resolution between Nevirapine and its degradation products.