VALIDATED STABILITY INDICATING HPTLC METHOD FOR ESTIMATION OF LAMIVUDINE AS BULK DRUG AND IN PHARMACEUTICAL TABLET DOSAGE FORM

Sandeep B. Swami, Padmanabh B. Deshpande*, Shraddha Jadhav, Shriram Temgire

ABSTRACT

A simple, precise and accurate stability-indicating high performance thin layer chromatographic (HPTLC) method has been developed and validated for the estimation of Lamivudine in pharmaceutical tablet dosage form. Chromatographic resolution of drug was achieved on aluminium-backed plates pre-coated with silica gel G60 F254 using Chloroform: Methanol: Formic acid (8: 2: 0.1, v/v/v) as the mobile phase. The drug was resolved satisfactorily with Rf value 0.38 ± 0.02. Densitometric analysis of was carried out in the absorbance mode at 271 nm. Forced degradation studies were conducted to check the stability of drug as per ICH guidelines. Lamivudine was found susceptible to all the analyzed stress conditions. Linear regression analysis showed good linearity with respect to peak area in the concentration range of 300-1800 ng band-1. The developed method has been successfully applied for the estimation of Lamivudine in tablet dosage form.

Keywords: Lamivudine, HPTLC, Stability indicating method, Method development, Validation.