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Title : ESTIMATION AND VALIDATION OF SOFOSBUVIR IN BULK AND TABLET DOSAGE FORM BY RP-HPLC
Authors : Ravikumar Vejendla, C.V.S. Subramanyam, G. Veerabhadram
Abstract : A simple, sensitive, precise, and accurate isocratic reverse phase high pressure liquid chromatographic method has been developed and validated for the estimation of sofosbuvir in bulk and tablet dosage form. To optimize, a column Phenomenex prodigy ODS-3V (150 mm x 4.6 mm, 5 µm), mobile phase mixture of methanol and (0.1%) tri-fluro acetic acid as buffer having pH of 3.2 in the ratio of (30:70 v/v) found to be an efficient system for elution of drug with good peak shape as well as retention time 2.990 min., flow rate 1.0 ml/min. at UV wavelength of 260nm. Quantitative linearity was obeyed in the concentration range of 100 to 600 µg/ml, the regression equations of concentration over their peak areas were found to be Y = 18864x + 58306 R² = 0.996, where Y is the peak area and X is the concentration of drug. The number of theoretical plates obtained was 2604.352 which indicate the efficient performance of the column. The limit of detection was 0.01 µg/ml and limit of quantification was 0.03 µg/ml, which indicates the sensitivity of the method the high percentage recovery indicates that the proposed method is highly accurate. No interfering peaks were found in the chromatogram indicating that excipients used in tablet formulation did not interfere with the estimation of the drug by the proposed RP-HPLC method.

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