Abstrakt

A rapid stability indicating LC method for stavudine using RR-LC

P.Raghuram, I.V.Soma Raju, J.Sriramulu

A simple, sensitive isocratic RR-LC method has been developed for the quantitative determination of Stavudine Related substances in bulk drug, used for the HIV Aids. The developed method is also applicable for the Assay determination. Efficient chromatographic separation was achieved on a C18 stationary phase with simple mobile phase combination delivered in a isocratic mode and quantification was carried out using ultraviolet detection at 265 nm at a flow rate of 0.5 mL min-1. In the developed RRLC method the resolution between Stavudine and its two potential impurities was found to be greater than 4.0. Regression analysis shows an r value (correlation coefficient) of greater than 0.9999 for Stavudine and it’s all the two impurities. This method was capable to detect all two impurities of Stavudine at a level of 0.05 % with respect to test concentration of 0.5 mg mL-1 for a 20 L injection volume. The inter day precision values for all four impurities and for Stavudine was found to be within 2.0%RSD at its specification level. The method has shown good and consistent recoveries for Stavudine four impurities (93.9-103.9). The drug was subjected to stress conditions of exposure to acid hydrolysis, Oxidation and thermal degradation. Considerable degradation was found to occur in acid hydrolysis and Thermal stress conditions. The developed RR-LC method was validated with respect to linearity, accuracy, precision.