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A VALIDATED STABILITY INDICATING RPHPLC METHOD FOR THE DETERMINATION OF EMTRICITABINE IN BULK AND CAPSULES

PRADEEP KUMAR^*1, S.C.DWIVEDI¹, ASHOK KUSHNOOR²

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A rapid, precise, accurate, specific and simple RP-HPLC (reversed phase – high performance liquid chromatography) method was developed for the assay of Emtricitabine from tablets. A High performance liquid chromatograph 10AT SHIMADZU- SPD10A, using Phenomenex - Luna RP-18(2),250X4.6mm, 5 μm column, with a mobile phase composition of buffer : acetonitrile [85:15 %(v/v)] was used. The flow rate of 1.0 mL min-1 and the effluent was detected at 280 nm. The retention time of Emtricitabine was 9.341 minutes. Linearity was observed over the concentration range of 20-600μg mL-1. The limit of detection was found to be 5.539μg mL-1 while the quantification limit was 16.786μg mL- 1. The accuracy of the proposed method was determined by recovery studies and was found to be 99.468% to 101.110 %. The commercial tablet formulation was successfully analyzed using the developed method and the proposed method is applicable to stability studies and routine analysis of Emtricitabine in bulk and pharmaceutical formulations. The proposed method was validated for various ICH (International Conference on Harmonization) parameters like linearity, limit of detection, limits of quantification, accuracy, precision, range and specificity.