STABILITY INDICATING HPTLC METHOD FOR ESTIMATION OF LOPINAVIR AND RITONAVIR IN FIXED-DOSE COMBINATION TABLETS.
Main Article Content
Keywords
Lopinavir(LPV) and Ritonavir(RTV), HPTLC, Forced degradation, Validation.
Abstract
A stability indicating simple, precise,accurate,rapid and validated HPTLC method for simultaneous estimation of Lopinavir and Ritanavir was successfully developed. The method is based on HPTLC separation of the two drugs followed by densitometric measurements of their spots at 266 nm.This method is based on HPTLC separation followed by UV detection at 266 nm. The separation was carried out on merck TLC aluminium sheets precoated with silica gel 60 F254 using a camag Linomat5 The mobile consists of Benzene: ethanol : aceticacid (7:3: 0.4% v/v) . Calibration curves were linear in range of 800-4800 ng/band and 200- 1200 ng/ band Lopinavir and Ritonavir respectively . LPV and RTV gave sharp and well defined peaks at Rf value are 0.63 and 0.44 respectively, Stress degradation study shows that sample degraded with acid and base hydrolysis, under oxidation, thermal and photolytic stress conditions.. No chromatographic interferences from the tablet excipients were found. The method was validated in accordance with the requirements of ICH guidelines.
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