Volume : 12, Issue : 06, June – 2025
Title:
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE DRUGS TO QUANTITATE BY RP-HPLC
Authors :
V. Mounika*, J. Hanna Blessy, Dr. Nagaraju Pappula, G. Indira Priyadarshini
Abstract :
A reverse-phase high-performance liquid chromatographic method (RP-HPLC) was developed to determine Emtricitabine and Tenofovir Disoproxil Fumarate in combined and tablet doses. Separation is carried out by using waters – HPLC system equipped with 1200 series isocratic pump; Rheodyne injector with 20 µl fixed volume loop, PDA detector, Inspire C18 (250 × 4.6 mm,5 µm ) column, used phosphate buffer (pH -6.8)- acetonitrile in gradient mode at flow rate of 0.25 ml/min used as a mobile phase and detection is carried out at 257nm at ambient temperature. The active pharmaceutical ingredient is extracted from the tablet dosage form using a mixture of phosphate buffer and acetonitrile (40:60) as a diluent. The calibration graphs were linear, and the method showed excellent recoveries in the tablet dosage form. The developed HPLC method was validated and meets the requirements delineated by the International Conference on Harmonisation (ICH) guidelines concerning linearity, accuracy, precision, and robustness. The intra-day and inter-day variation was found to be less than 1%. The method was reproducible and selective for estimating Emtricitabine and Tenofovir Disoproxil Fumarate.
Keywords: Rp-Hplc, Emtricitabine, Tenofovir Disoproxil Fumarate.
Cite This Article:
Please cite this article in press V. Mounika al., Analytical Method Development And Validation Of Emtricitabine And Tenofovir Disoproxil Fumarate Drugs To Quantitate By Rp-Hplc, Indo Am. J. P. Sci, 2025; 12(06).
Number of Downloads : 10
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