Analytical Method Development and Validation for Simultaneous Estimation of Lamivudine and Zidovudine in Tablet Dosage form by RP-HPLC

Abstract

A new, precise, rapid, accurate RP-HPLC method was developed for the  Simultaneous Estimation of Lamivudine and Zidovudine in pharmaceutical dosage forms. Chromatographic separation was achieved with mobile phase consisting of Ammonium acetate buffer pH 4.0, Acetonitrile and THF in the ratio of 60:30:10 v/v as the mobile phase with Inert sil ODS C18 (250 × 4.6 mm I.D) 5 µm, column as stationary phase at flow rate of 1  mL/min and detection wavelength of 240 nm. The  retention times of  Lamivudine and Zidovudine was found to be 3.793 min and 2.547 min respectively. The method was validated in terms of Linearity, Range, Accuracy, Precision, Specificity, LOD, LOQ, Robustness and system suitability according to ICH guidelines. Commercial tablet formulation was successfully analyzed using the developed method and the proposed method is applicable to routine analysis for determination of Lamivudine and Zidovudine in tablet dosage form.