Method Development, Validation and Forced Degradation Studies of Ritonavir, An Retroviral Drug Using UV-Visible Spectroscopy

Abstract

The aim of the present work is to develop sensitive, simple, accurate, precise and cost effective UV-spectrophotometric method for the determination of Ritonavir, an anti-retroviral drug, in bulk and pharmaceutical dosage form; and also to monitor the degrada-tion behavior of the drug under different stress conditions according to ICH guidelines.The method was developed by checking the solubility of the ritonavir in various solvents. Ritonavir is found to be freely soluble in the methanol and acetonitrile.The method was developed using methanol and acetonitrile.The absorbance maxima of ritonavir using methanol was found to be at 239nm.The method showed high sensitivity of linearity range from 10-60 ?g/ml with a correlation coefficient (r) of 0.9999 .The validation parameters were reported along with Limit of Detection( LOD) and Limit of Quantification(LOQ).The degradation behavior of the drug was studied by subjecting Ritonavir to an acid and alkaline hydrolysis, oxidative, thermal and UV degradation. This study indicated that Ritonavir was degraded in different stress conditions.