Abstract

Objective: To develop and validate stability indicating HPTLC method for determination of Rilpivirine and Dolutegravir Sodium Methods: The chromatographic development was carried out on aluminum plates pre-coated with silica gel 60 F254 as stationary phase using Toluene: Methanol: Ethyl acetate: Tri Ethyl Amine (5.5:1:1.5:0.1 v/v/v/v) as mobile phase. Detection wavelength chosen was 258 nm. Result: The retention factor (Rf) for Rilpivirine was found to be 0.52 ± 0.02 and retention factor (Rf) for Dolutegravir Sodium was found to be 0.24± 0.02. The drugs were subjected to stress testing as per ICH Q1A (R2).There was no interference of any degradant at Rf of Rilpivirine and Dolutegravir Sodium. The developed method was successfully validated according to ICH Q2R1 guidelines. The calibration curve was found to be linear over a range of 400 - 2000 ng/ band. The accuracy of the method is indicated by good recovery in the range of 95.49% - 101.66% for Rilpivirine and of Dolutegravir Sodium 99.16% - 101.48% with less than 2% of RSD. The limit of detection and limit of quantification of Rilpivirine was found to be LOD-123.75 ng/band and LOQ-375.01 ng/band and for Dolutegravir Sodium was found to be LOD-109.03ng/band and 330.41ng/band. Conclusion: A new simple, accurate, precise and specific stability- indicating high performance thin layer chromatographic (HPTLC) method has been developed and validated for determination of Rilpivirine and Dolutegravir Sodium in combination. We have developed HPTLC method wherein the stress conditions were optimized to achieve 10-30 % degradation.