RP-HPLC stability method development & validation for anti-HIV drugs cabotegravir & rilpivirine in I.M. injection and in human plasma

Abstract

In Pharmaceutical & Medical Health Sciences there are necessities for development of analysis methods for medicines in various dosage forms. Currently the use of RP-HPLC is primarily applied for testing of medicines in various dosage forms, and to study bio analysis in human plasma matrix. The present method is developed for analysis of anti HIV drugs cabotegravir CAB and rilpivirine RILP in pure api & Intramuscular Injection dosage forms, and also in human plasma. The HPLC method is optimized for analysis of these two drugs in combined forms for swift analysis with very less amount of drugs utilized for testing purposes. The concentration range used for the linearity studies is 2.5 to 15µg/ml for CAB cabotegravir & for Rilpivirine RILP it is 3.75 to 22.5µg/ml. Wavelength selected for estimation is 242.5nm and column used was Kinetex C-18 column (250mm x 4.6mm, 5 µm id). The Retention-time obtained were 2.14min for CAB & 3.12min for RILP. The R2 was found to be 0.999 for both drugs. The method is applied for analysis of drugs in i.m. injections, individually & in combined forms. The Stability & forced-degradations studies were carried out in different stress conditions and the impurities & pure drugs, are efficiently detected by the developed HPLC method.