Validation of a Quantitative Method for Simultaneous Estimation and Comparison of Dissolution Method for Combination Tablet of Lamivudine and Zidovudine

A simple, precise and accurate HPLC method has been validated to measure lamivudine and zidovudine at single wavelength (270 nm) in order to assess in vitro drug release profile of drug from tablet formulation. The chromatographic separation was achieved on a Hypersil SS C18 (250 mm × 4.6 mm, 5μm) analytical column. Methanol was used as the mobile phase, at a flow rate of 1 ml/min. The release of lamivudine and zidovudine from in dissolution medium (distilled water) and in the reference dissolution medium (0.1 N HCl) was studied using the USP type II apparatus. The parameters similarity factor, according to current FDA guidelines, dissolution efficiency, t50 and dissolution rate constant (k) were employed to compare dissolution profiles. It was concluded that test dissolution method was equivalent to the reference dissolution method.