Development and Validation of Stability Indicating HPTLC Method for Estimation of Dolutegravir

Smruti C. Shinde, Ayushi S. Gadekar, Anuruddha R. Chabukswar, Santosh V. Gandhi 1

8th WCPSDM.2021. APR.Published Online 18 APR 2021

Abstract : Dolutegravir is in a class of medications called HIV integrase inhibitors. It works by decreasing the amount of HIV in your blood and increasing the number of immune cells that help fight infections in your body. A Stability indicating High Performance Thin Layer Chromatographic Method was developed and validated for the estimation of Dolutegravir which comply with the ICH Q2(R1) guidelines. The chromatographic method was developed on a aluminium plates pre-coated with silica gel 60 GF254. The Mobile Phase was composed of ethyl acetate: methanol (9:1 v/v). The retention factor (Rf) was found to be 0.48±2.005. The densitometric scanning was carried at 258 nm. The calibration curve showed good linear relationship with R2 = 0.9976 in the range of 200-1200 ng/band. To assess the stability of the drug under different stress conditions it was subjected to different stress conditions like acid, alkaline, oxidative, dry heat and photolytic degradation. Dolutegravir found to be degraded under all stress conditions except photodegradation. Further LC-MS analysis of stress samples was carried out to understand degradation behavior of Dolutegravir.