Stability-Indicating RP-UPLC Method Development and Validation for Tenofovir, Lamivudine, and Doravirine as per ICH Guidelines

Abstract

This study primarily focused on developing a new stability-indicating method for tenofovir, lamivudine, and doravirine (TNF, LMV, and DRV). Successfully, a new stability-indicating method was developed for these drugs due to their exposure to various stress conditions such as hydrolysis, oxidation, thermal, and photolytic environments. These drugs were found to be sensitive to all forced degradation conditions and degraded by 3.07 to 7.34%. All degradation impurities were separated and quantified simultaneously using the developed UPLC method. The method was also validated according to ICH guideline Q2 (R2). It demonstrated good accuracy, with recovery values between 99.33% and 100.55%. Precision was also good, with RSD values of 0.7, 0.6, and 1.0 for TNF, LMV, and DRV. In the linearity test, the method showed a strong correlation coefficient (R²) of more than 0.999. LOD and LOQ values were also established using signal-to-noise ratios.