Development and Validation of a Stability Indicating HPLC Method for Efavirenz and Assessment of Its Degradation Profile Under ICH-Mandated Stress Conditions

A stability-indicating HPLC method was developed and validated for Efavirenz, a non-nucleoside reverse transcriptase inhibitor. The method effectively separated Efavirenz from its degradation products under various stress conditions, including acidic, alkaline, oxidative, thermal, and photolytic stress. The results showed that Efavirenz is highly labile to alkaline hydrolysis and moderately susceptible to acidic hydrolysis and oxidation. The method was linear, accurate, precise, and robust, with a mean recovery of 98.9-101.2% and RSD < 1.5%. The study provides a comprehensive degradation profile of Efavirenz, confirming its vulnerability to hydrolysis, especially in alkaline environments. This method is suitable for routine quality control and stability monitoring of Efavirenz in pharmaceutical formulations.