Advanced Analytical Method Development and Validation for Comprehensive Impurity and Chiral Impurity Analysis of Cobicistat in Anti-Retroviral Regimens

The rising application of cobicistat as a pharmacokinetic booster in antiretroviral therapy requires accurate and efficient biophysical and chiral analyses of impurities and enantiomers. This work describes a new analytical technique that has been created and tested for the identification of impurities and determination of chiral purity of cobicistat. While employing advanced chromatographic methods, it proves that sensitivity as well as specificity is very high in terms of detecting and measuring the level of impurities. In addition, to have the pure form of the drug, chiral separation was also carried out to prevent the formation of racemic mixture. Some of the validated parameters for the method were linearity, accuracy, precision, limit of detection, limit of quantification and robustness. The obtained results proved that the developed method is reliable, sensitive, accurate and suitable for routine quality control of cobicistat and its efficacy and safety in the clinical practices.