Monday , 24 June 2024

Analytical Method Development and Validation for the Simultaneous Estimation of Darunavir and Cobicistat by RP-HPLC Method in Bulk and Pharmaceutical Dosage Form

Sd. Asra Ayesha*, G. Devika Subramaniyan
Bomma Institute of Pharmacy, Allipuram, Khammam, Telangana, India

A new, simple, precise, accurate and reproducible RP-HPLC method for simultaneous estimation of Darunavir and Cobicistat in bulk and pharmaceutical formulations was developed. Separation of Darunavir and Cobicistat was successfully achieved on C18 ODS(250mm x 4.6 mm), 5µm., column in an isocratic mode utilizing sodium acetate buffer pH 4.5:methanol (60:40v/v) at a flow rate of 1.0 ml/min and eluents were monitored at 253nm, with a retention time of 2.577and 4.967minutes for Darunavir and Cobicistat respectively. The method was validated and it was found to be linear. The values of the correlation coefficient were found to 0.992 for Darunavir and 0.9992 for Cobicistat respectively. The LOD for Darunavir and Cobicistat were found to be 19.07 and 0.28respectively. The LOD and LOQ for Darunavir and Cobicistat were found to be 57.78 and 2.47respectively. The percentage recoveries for Darunavir and Cobicistat were found to be within the limit indicates that the proposed method is highly accurate. The method was extensively validated according to ICH guidelines.
Keywords: Darunavir, Cobicistat, RP-HPLC

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