NEW STABILITY INDICATING HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF LAMIVUDINE, TENOFOVIR DF AND NEVIRAPINE IN EXTENDED RELEASE TABLETS
*Lanka A. Rama Prasad, J.V.L.N.S. Rao, Srinivasu Pamidi, J. Vara Prasad and J. Hemalatha
New stability-indicating reverse phase LC method developed and validated for the simultaneous estimation of Lamivudine, Tenofovir DF and Nevirapine in extended release tablet dosage form.&nbsp; Tenofovir and Lamivudine are formulated into immediate release and Nevirapine into extended relase. The chromatographic conditions were optimized using an impurity-spiked solution and the samples generated from forced degradation studies. The chromatographic separation was achieved on a core shell technology C18 stationary phase. The method employed a linear gradient elution and the detection wavlength was set at 260 nm. The mobile phases consists of buffer and acetonitrile delivered at a flow rate of 0.7 mL&bull;min&ndash;1. Proposed method was extensively validated as per ICH guidelines. Regression analysis shows an r value (correlation coefficient) of greater than 0.999 for individual active drug substances. The samples were assayed against a qualified reference standard and the mass balance was found to be close to 98.3%.
International Journal Of Pharmacy
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