Abstract
An efficient, simple and robust stability indicating RP-HPLC method has been developed and validated for the estimation of Lamivudine and Zidovudine as per ICH guidelines in pharmaceutical dosage form. Elution was carried out in an gradient mode on reverse phase C18 (Gemini 250x4.6mm 5μ) column using mobile phase as Acetonitrile and 1% Acetic acid in water at 0.6mL/min flow rate, 20μL/mi injection volume, 25oC column temperature and 279nm as detection wavelength. The stability indicating capability of the method was analysed by degrading the samples in stress conditions. A good linear response for Lamivudine and Zidovudine was obtained in the range from 50-100000ng/mL and 100-200000ng/mL respectively. The LOD and LOQ found to be for Lamivudine were 2.20ng/mL and 6.66ng/mL and that for Zidovudine was 4.86ng/mL and 4.86ng/mL. Rugged and robust in different testing criteria, the method was quantitatively evaluated in terms of accuracy (recovery), linearity, precision, selectivity in accordance with standard guidelines. The method is sensitive, suitable and conductive for analysing Lamivudine and Zidovudine in bulk and pharmaceutical dosage forms.
Published Version
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