Analytical metthod development and validation for the simultaneous estimation of lamivudine and zidovudine by reverse - phase high - performance liquid chromatography in bulk and tablet dosage forms
A simple, rapid, accurate, precise, and reproducible validated reverse-phase high-performance liquid chromatography (HPLC) method was developed for the determination of lamivudine and zidovudine in bulk and tablet dosage forms. The quantification was carried out using symmetry PremsilC18 (150 mm × 4.6 mm, 5 μm) column run in isocratic way using mobile phase comprising of acetonitrile: water (0.05% orthophosphoric acid with PH 3) 50:50 v/v and a detection wavelength of 271 nm and injection volume of 20 μL, with a flow rate of 0.5 ml/min. The retention times of lamivudine and zidovudine were found to be 6.200 min and 3.616 min, respectively. The method was validated in terms of linearity, precision, accuracy, limit of detection, limit of quantification, and robustness in accordance with the ICH guidelines. The assay of the proposed method was found to be 99-101%. The recovery studies were also carried out, and mean % recovery was found to be 99-101%. The % RSD from reproducibility was found to be <2%. The proposed method was statistically evaluated and can be applied for routine quality control analysis of lamivudine and zidovudine in bulk and tablet dosage form.
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