ISSN 2348-1218 (print) International Journal of Interdisciplinary Research and Innovations ISSN 2348-1226 (online) Vol. 8, Issue 2, pp: (84-92), Month: April - June 2020, Available at: www.researchpublish.com
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF DOLUTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE BY HPLC IN BULK AND PHARMACEUTICAL DOSAGE FORM 1
Ms. Maitri Jayantibhai Patel, 2Sharda
School of Pharmacy, Pethapur, Gandhinagar, Gujarat.
Abstract: A simple, rapid, economical, precise and accurate HPLC method for simultaneous estimation of Dolutegravir, Emtricitabin And Tenofovir Alafenamide in their combined dosage form has been developed. A indicating reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of Dolutegravir, Emtricitabin And Tenofovir Alafenamide in their combined dosage form. The separation was achieved by C18 (250mm x 4.6 mm i.d.,5µm) column and Buffer (pH 5.0): Methanol (50:50) at a flow rate of 1 ml/min. Detection was carried out at 263 nm. Retention time 4.653 min, 5.603 min and 11.083 min for Dolutegravir, Emtricitabine And Tenofovir Alafenamide respectively. The method has been validated forlinearit y, accuracy and precision. Linearity observed for Dolutegravir 5-15 μg/ml, Emtricitabine 20-60 μg/ml and for Tenofovir Alafenamide 2.5-7.5 μg/ml. Developed method was found to be accurate, precise and rapid for simultaneous estimation of Dolutegravir, Emtricitabine And Tenofovir Alafenamide in their combined dosageform. The proposed method was successfully applied for the simultaneous estimation of both the drugs in commercial Combined dosageform. The drug was subjected to stress condition of hydrolysis, oxidation, photolysis and Thermal degradation, Considerable Degradation was found in Thermal degradation. The proposed method was successfully applied for the simultaneous estimation of both the drugs in commercial Combined dosage form. Keywords: Dolutegravir, Emtricitabin And Tenofovir Alafenamide simultaneous estimation, HPLC Method, validation.
1. INTRODUCTION Emtricitabine is 5-fluoro-1-(2R,5S)-[2-(hydroxymethyl)-1,3 oxathiolan-5-yl]cytosine. Emtricitabine, a synthetic nucleoside analog of cytidine, is phosphorylated by cellular enzymes to form emtricitabine 5'-triphosphate. Emtricitabine 5'-triphosphate inhibits the activity of the HIV-1 reverse transcriptase by competing with the natural substrate deoxycytidine 5'-triphosphate and by being incorporated into nascent viral DNA which results in chain termination. Emtricitabine 5’-triphosphate is a weak inhibitor of mammalian DNA polymerase α, β, ε, and mitochondrial DNA polymerase γ.
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