Development and Validation of Stability Indicating Method for Darunavir with Forced Degradation Studies Using LC-ESI-MS/MS

摘要

Darunavir is a non-peptidic, second generation protease inhibitor used to treat HIV infection. Stability testing is main component in the pharmaceutical development program for a new drug as well as new formulation. Herewith forced degradation studies were carried out in accordance with the ICH guideline Q1A (R2). Darunavir was found to degrade in basic and oxidative stress conditions. Resolution of the drug and degradation products was achieved on a Hi-Q Sil C-18 column (4.6 x 250 mm, 5 μm) utilizing acetonitrile, water (90:10 % v/v) of pH 5 at a flow rate of 1 mL/min and at the detection wavelength 266 nm.