Abstract
A simple, precise, accurate, reproducible, rapid and economical stability- indicating reverse phase liquid chromatography method was developed and validated for the quantitative simultaneous estimation of Lamivudine and Zidovudine, in bulk and marketed formulations. Estimation of drugs in this combination was done with a Kromasil 100-5C18 column [250mm x 4.6mm] using a filtered and degassed mobile phase of composition Methanol and Water (50:50 v/v). The flow rate was 0.8 ml/min and the separation was monitored at 270 nm by using UV variable wavelength detector. The retention time of Lamivudine and Zidovudine were 3.3 min and 5.0 min respectively. The method was found to be linear over a range of 5-25 g/ml for Lamivudine and 10-50 g/ml for Zidovudine. The stressed samples were analyzed and this proposed method was found to be specific and stability indicating as no interfering peaks of degradation compounds and excipients were noticed. The method was validated according to the guidelines of International Conference on Harmonization (ICH) and was successfully employed in the estimation of commercial formulations. The obtained results proved that regression value for linearity, %RSD values for precision and percentage recovery for accuracy was within the specified limits. Hence the proposed method can be utilized for qualitative and quantitative estimation of selected drugs by the modern analyst with 100% confidence.
