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Abstract

The purpose of this research was to create an RP-HPLC technique that could detect cobicistat and darunavir simultaneously while
being quick, easy, and accurate. To provide sufficient separation of all three medicines with internal standard, a variety of solvents,
buffer-solvent ratios, and flow rates were investigated throughout the development of the procedure. The results of validating the
proposed method showed that it meets ICH standards Q2 R1.A Xterra C18 5m (4.6*250mm) column was used to separate Cobicistat
and Darunavir at a flow rate of 1 ml/min, a mobile phase ratio of Phosphate buffer (0.05M) pH 4.6: ACN (55:45%v/v) (pH was
adjusted with orthophosphoric acid), and a detection wave length of 255 nm. The instruments utilized in this analysis were a
WATERS HPLC Auto Sampler, a separation module 2695, a PDA detector 996, and Empower-software version 2. You will recall
both 2.39 and 3.907 minutes, according to the computer. Laboratory analysis confirmed that Cobicistat and Darunavir were 99.9
percent and 101.4 percent pure, respectively. Combining Cobicistat and Darunavir resulted in a resolution of 8.0, theoretical plates of
1.3, and a tailing factor of 1.4. The validation of the analytical technique was carried out in accordance with ICH standards (ICH,
Q2 (R1)). Cobicistat and Darunavir were found to have linear concentration-response curves from 1 to 5 grams and 100 to 500
grams, respectively, with mean recoveries of 100 and 100.5, repeatability standard deviations (RSDs) of 2 and 4, and intermediate
RSDs of 5 and 16 percent, respectively