Abstract

STRESS DEGRADATION STUDIES ON DARUNAVIR ETHANOLATE USING VALIDATED STABILITY-INDICATING HIGHPERFORMANCE THIN-LAYER CHROMATOGRAPHY

Palak G. Chaudhary and Prof. Dr. Dhrubo Jyoti Sen

Abstract

Darunavir Ethanolate is a novel nonpeptidic human immunodeficiency virus type 1 (HIV-1) protease inhibitor (PI). A sensitive, selective, accurate, precise and stability-indicating high-performance thin-layer chromatographic method for analysis of Darunavir Ethanolate has been developed and validated. The method uses aluminum-backed silica gel 60F254 plates with toluene – ethyl acetate – methanol 6.5:2.0:1.5 (v/v) as mobile phase. The system gave compact bands for Darunavir Ethanolate (RF 0.37). Densitometric analysis of Darunavir Ethanolate was performed in absorbance mode at 270 nm. The method was linear in the range of 500-3500 ng/band (R2 = 0.9995). The limits of detection and quantification were 130 and 390 ng per band, respectively. Darunavir Ethanolate was subjected to different stress conditions – acid and alkaline hydrolysis, oxidation, photo degradation and thermal degradation. The degradation products were well resolved from the pure drug with significantly different RF values. Since the method could effectively separate the drug from its degradation products, it could be used as a stability-indicating method for analysis of Darunavir Ethanolate.

Keywords: Darunavir Ethanolate (DRV), HPTLC, Stress degradation, Validation, Limit of Detection (LOD), Limit of Quantitation (LOQ), RSD, ICH.