Development and Validation of a UV Spectroscopic Method for Quantitative Analysis of Nevirapine in Bulk Drug Substances

Abstract

Nevirapine is an innovative anti-HIV drug. Currently, there is no straightforward UV spectrophotometric method for its estimation. Therefore, a new, cost-effective, precise, linear, sensitive, and accurate UV spectrophotometric method is necessary. Given Nevirapine's broad potential formulations for HIV treatment, we aimed to develop and validate this method in line with ICH guidelines. This method utilized Ethanol as the solvent, with Nevirapine showing an absorption maximum at 351 nm. Spectral analysis was performed using a UV-Visible spectrophotometer. The developed method demonstrated linearity within a range of 10-60 µg/ml, with an excellent correlation coefficient of 0.9944. Method accuracy was confirmed through a recovery study, showing drug recovery between 98.8% and 99.7%. The intraday precision relative standard deviation (RSD) was 0.972%, and interday precision RSD ranged from 0.26% to 0.45%. The RSD was consistently below 2%, indicating high precision. The linearity, accuracy, precision, and robustness of the proposed UV spectrophotometric method were statistically validated, confirming its suitability for routine Nevirapine analysis.