Abstract

METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF EMTRICITABINE, BICTEGRAVIR AND TENOFOVIR IN BULK AND TABLET DOSAGE FORM BY RP-HPLC METHOD

Nagaraju Pappula* and Achyutha Dharma Teja

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Abstract

A stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method with a high sensitivity was developed for simultaneous estimation of Emtricitabine, Bictegravir and Tenofovir in pharmaceutical dosage form. Chromatographic separation of Emtricitabine, Bictegravir and Tenofovir were successfully achieved on an Agilent C18 (150×4.6mm, 5μ) with an mobile phase composed of a mixture of 0.01N Na2 HPO4: acetonitrile (50:50, v/v) at a flow rate of 1.00 mL min−1. The drugs were quantified using a wavelength of 272 nm. The reversed-phase HPLC method has been validated as per International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines. The proposed method showed a good linearity in the concentration range of 25–150 μg/mL for Emtricitabine, 6.25-37.5 μg/mL for Bictegravir and 3.125-18.75 μg/mL for Tenofovir under optimized conditions. The statistical performance of the HPLC method was fully validated and the performance results of the proposed HPLC method were considerably satisfactory with reference to the RSD values of validation parameters like linearity, system precision, method precision, robustness, ruggedness etc.,. The validated method was successfully applied to quantify the Emtricitabine, Bictegravir and Tenofovir in tablet form.

Keywords: Emtricitabine, Bictegravir and Tenofovir, RP-HPLC.