Development and Validation of a HPLC Method for Simultaneous Estimation of Lamivudine and Zidovudine in Tablet Dosage Forms

摘要

A simple, precise and accurate HPLC method has been developed for the simultaneous estimation of lamivudine and zidovudine in tablet formulations. 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 and detector wavelength at 270 nm. The validation of the method was accomplished for specificity, linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ) and robustness. The linear dynamic ranges were from 0.1–2.0μg/ml for lamivudine and zidovudine. The percentage recovery obtained for lamivudine and zidovudine were 100.36 and 100.46 %, respectively. Limit of detection and quantification for lamivudine were 0.042 and 0.12 μg/ml, for zidovudine 0.039 and 0.12 μg/ml, respectively. The developed method can be used for routine quality control analysis of lamivudine and zidovudine in combination in tablet formulation.