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.
Title: ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF DOLUTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE BY HPLC IN BULK AND PHARMACEUTICAL DOSAGE FORM
Author: Ms. Maitri Jayantibhai Patel, Sharda
International Journal of Interdisciplinary Research and Innovations
ISSN 2348-1218 (print), ISSN 2348-1226 (online)
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