A novel RP-HPLC method development and validation of Cobicistat in bulk drug and tablet dosage form

The literature review reveals that there are some analytical methods reported for Cobicistat by RP-HPLC method and most of the work was done on biological fluids. Present study aims to develop a specific, precise, accurate, rapid, sensitive and faster elution RP-HPLC method for the estimation of Cobicistat in bulk and pharmaceutical dosage form, using laboratory chemicals. Chromatography was carried on reverse phase C18 (4.6 x 100 mm, 5mm, Make: Phenomenex) column, in an isocratic mode using a combination of methanol and water in the ratio of 20:80 v/v as mobile phase at a flow rate of 0.8 ml/min with UV detection at 249 nm. The selected chromatographic conditions were found to analyze Cobicistat (retention time = 4.7 min). The different analytical performance parameters such as linearity, precision, accuracy, specificity, limit of detection and limit of quantification were determined. The linearity of the calibration curve for each analyte in the desired concentration range is good (r2>0.9) The recovery of the method was between 98-102%. Hence, the proposed method is highly sensitive, precise and accurate and it may be successfully applied for the reliable quantification of API content in the commercial formulation of Cobicistat.

Author(s): Urooj Fatima

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