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ISSN 2063-5346
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RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF DARUNAVIR IN TABLET DOSAGE FORM

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Amjad Ali M.Iqbal, Sayali S. Gaikwad, Ashwini Patil, Shakeel .A. Choudhary, Kaleem Mazhar Petkar
» doi: 10.31838/ecb/2023.12.s3.633

Abstract

A simple, economic, sensitive and reliable RP-HPLC method was developed for Darunavir in tablets.From literature survey it was decided to perform gradient mode as other articles were of isocratic mode. Gradient chromatography was analysed on a C18 column with mobile phase (A) as buffer and mobile phase (B) as ACN at a flow rate 1.5 ml/min. The effluent was monitored by UV- detector at 265 nm and overall run time was 15 mins.Calibration curve was linear over the concentration range of 50-150μg/ml. The developed method was validated with respect to ICH guidelines following accuracy,linearity, precision, selectivity and robustness, these parameters examined were in the acceptable limits for analytical method validation.Robustness of the developed method was estimated by making small changes in flow rate (±1ml/min), column temperature(±5%), organic mobile phase ratio (±10%), along with the optimized method.Stability study of solution and force degradation studies was also carried out and found to be satisfactory.The percentage purity of Darunavir was found to be 99.9% and %RSD values for Darunavir were within limit of ≤2.The developed and validated RP-HPLC method was successfully applied for the quantitative estimation of Darunavir in marketed formulation.

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