A stability indicating RP-HPLC method for simultaneous estimation of darunavir and cobicistat in bulk and tablet dosage form

[摘要] The purpose of the present investigation was to develop a new RP-HPLC method for simultaneous estimation of Darunavir and cobicistat as per ICH guidelines. The HPLC separation was carried out by reverse phase Chromatography was carried out on an BDSC 18column (4.6x150mm, 5μ particle size) with a isocratic mobile phase composed of ortho phosphoric acid buffer, Acetonitrile, (50:50v/v) at a flow rate of 1mL/min. The column temperature was maintained at30°C and the detection was carried out using a PDA detector at 210nm. The retention times for Darunavir and cobicistat and were 2.018 min and 2.721 min respectively. The percentage recoveries of Darunavir and cobicistat were 99.97 % and 99.95 % respectively. The relative standard deviation for assay of tablets was found to be less than2%. The % RSD for method precision was found to be 0.9 for both Darunavir and cobicistat. The correlation coefficient for Darunavir and cobicistat was found to be 0.9994 and 0.9996 respectively. The detection limits were found to be 0.039μg/mL and 0.210μg/mL for Darunavir and cobicistat respectively. The quantitation limits were found to be 0.117μg/mL and 0.638μg/mL for Darunavir and cobicistat respectively. The proposed method was fast, accurate, precise and sensitive hence it can be employed for the simultaneous quantification of Darunavir and cobicistat in the dosage form, bulk drugs as well as for routine analysis in quality control.

[学科分类] 药理学