Journal of Chemical and Pharmaceutical Research (ISSN : 0975-7384)

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Original Articles: 2010 Vol: 2 Issue: 1

Method development and validation of RP-HPLC method for simultaneous determination of Lamivudine and Zidovudine

Abstract

A rapid, sensitive and specific RP-HPLC [1-5] metho d involving UV detection was developed and validated for determination and quant ification of Lamivudine and Zidovudine. Chromatography was carried out on a pre-packed Alti maC18 5μ (150*4.6mm) column using filtered and degassed mixture of Ammonium acetate b uffer:Methanol (80:20) as mobile phase at a flow rate of 1.0ml/min and effluent was monitored at 270nm. The method was validated in terms of linearity, precision, accurac y, and specificity, limit of quantification and limit of detection. The assay was linear over the concentration range of Lamivudine and Zidovudine was 37.5mcg-112.5mcg/ml and 75mcg to 225 mcg/ml respectively. Accuracy of the method was determined through recovery studies by adding known quantities of standard drug to the pre analyzed test solution and was foun d to be 98.50%-99.9% and 98.30%- 100.10% within precision RSD of 0.71 and 0.82 for L amivudine and Zidovudine respectively. The system suitability parameters su ch as theoretical plates and tailing factor were found to be 3189.33, 1.12 and 7852.83, 1.05 re spectively for Lamivudine and Zidovudine. The method does require only 20 minutes as run time for analysis which prove the adoptability of the method for the routine qual ity control of the drug.