Abstract

Validated stability indicating RP-HPLC method for the determination of Cobicistat in bulk and pharmaceutical formulations

Author(s): K.Sureshbabu, B.Koteswararao, C.Rambabu

A new validated RP-HPLC method was developed for the determination of Cobicistat in dosage form. The developed method produced high sensitivity, precision and accuracy. An isocratic C18 (Hypersil BDS, 150 mm x 4.6 mm, 5µ) column was used with mobile phase of composition acetonitrile : phosphate buffer (10 : 90 at pH 6.5) at a flow rate of 1.0 mL/min with UV detection at wavelength of 240 nm for Cobicistat. The retention time of the drug was 4.078 minutes. The developed method was validated for specificity, linearity, precision, accuracy and robustness as per ICH guidelines. Linearity was found in the range of 7.5 – 45.0 µg/ml. The percentage recoveries of the drug ranged from 99.23 – 99.97 %. Forced Degradation study was carried out by treating the sample under the acidic, alkaline, thermal and photo conditions. The results indicated that the any other impurity is not merging with the main peak. The proposed method could be used for routine analysis of Cobicistat in their dosage forms.