Articles Accepted

DEVELOPMENT AND VALIDATION OF RP HPLC METHOD FOR THE ESTIMATION OF SOFOSBUVIR IN BULK, TABLET AND APPLIED IN PHARMACEUTICAL INDUSTRIAL WASTE
by Dr. K Vijaya sri, 15 Jan 2019

Development and validation of RP-HPLC method for estimation of Sofosbuvir in bulk, pharmaceutical dosage form and applied in pharmaceutical industrial waste. The chromatographic separation was performed on Agilent syncronis C18 (100 mm × 4.6 mm, 5μm) column, with a mobile phase comprising of a mixture of methanol: acetonitrile: water (45:30:25 v/v).The flow rate was 1.0 mL/min with detection at 260 nm. Retention time of sofosbuvir was found to be 2.040 min. As per ICH guidelines, the method was validated for linearity, accuracy, limit of detection, limit of quantitation, precision, robustness and system suitability. Linearity was found to be in the range of 4-24 µg/ml with regression equation y = 675284.x + 49120 and correlation coefficient 0.999. The low % RSD values are indicates the method is accurate and precise. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.046 and 0.1400 µg/ml, respectively. The % recovery of tablets was found to be in the range of 99.9– 101.3%. It can be concluded that this validated HPLC method is easy, precise, accurate, sensitive and selective for estimation of sofosbuvir in bulk, tablet and applied in pharmaceutical industrial waste.

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