DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR ESTIMATION OF DARUNAVIRAbstract
A simple, precise, and sensitive stability-indicating high-performance thin layer chromatographic (HPTLC) method has been developed and validated for the analysis of Darunavir in bulk and in the tablet dosage form. The separation was performed on pre-coated silica gel 60 GF254 plates using Toluene: Methanol: Triethylamine (8.5:1:0.5 v/v/v) as the mobile phase. The retention factor (Rf) was found to be 0.61 ± 0.89. The detection of a band was carried out at 267 nm. The drug was subjected to different stress conditions like acid, base hydrolysis, oxidation, thermal degradation, and photolysis. The method was successfully validated according to ICH Q2 (R1) guidelines. The linear regression analysis data for the calibration plot showed a good linear relationship with R2 = 0.992 in the range of 500-3000 ng band-1. The method found to be accurate as results of the recovery studies are close to 100%. The developed method can be adopted for routine analysis of Darunavir in bulk and pharmaceutical dosage form.
A. R. Chabukswar and A. S. Gadekar *
Department of Pharmaceutical Chemistry, MAEERS Maharashtra Institute of Pharmacy, Kothrud, Pune, Maharashtra, India.
29 July 2019
21 December 2019
02 March 2020
01 July 2020