RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF COBICISTAT AND DARUNAVIR IN BULK AND PHARMACEUTICAL DOSAGE FORM

T  Sankarshana; Md.  Musthafa

doi:10.22270/ijmspr.v3i1.19

Authors

T Sankarshana Osmania University, Department of Chemistry, Hyderabad, Telangana
Md. Musthafa Osmania University, Faculty of pharmacy, University College of Pharmacy, Hyderabad

DOI:

https://doi.org/10.22270/ijmspr.v3i1.19

Keywords:

RP-HPLC, Cobicistat, Darunavir, Prezcobix, Validation

Abstract

A stability indicating RP-HPLC method has been developed and subsequently validated for the simultaneous estimation of cobicistat and darunavir in API and tablet dosage form. Optimized chromatographic condition were achieved by Eclipse XBD-C18(250mm x 4.6mm, 5µ) column, mobile phase as a mixture of buffer (0.01M potassium dihydrogen phosphate, pH-3.0): acetonitril in the ratio of 40:60v/v with a flow rate of 1ml/min., UV detection was performed at 240nm and the sample temperature was maintained ambient which was injected manually. This developed method for simultaneous estimation of cobicistat and darunavir is linear over a range of 40 – 120 % and 40 -120 % respectively. The validation parameters as per ICH guide lines show good precision having 0.066 and 0.039 %RSD for cobicistat and darunavir which shows nice repeatability, limit of detection and limit of quantification for cobicistat and darunavir was found to be 0.02 and 0.06 and 0.02 and 0.06 % respectively. The developed method is easy to perform assay for indicating quality control determinations in bulk and formulated form with rapid, selective and stability indicating

Author Biographies

T Sankarshana, Osmania University, Department of Chemistry, Hyderabad, Telangana

Osmania University, Department of Chemistry, Hyderabad, Telangana

Md. Musthafa, Osmania University, Faculty of pharmacy, University College of Pharmacy, Hyderabad

Osmania University, Faculty of pharmacy, University College of Pharmacy, Hyderabad

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