A Rapid RP-Hplc Stability Method Development & Validation For Antiviral HIV Drugs Cabotegravir & Rilpivirine In I.M. Injection

Abstract

In pharmaceutical analysis for the medicinal agents & dosage forms new sophisticated chromatographic methods are utilized for the quality control purpose. There are necessities for new medicinal agents for the treatment therapy for various diseases. Novel antiviral drugs and their combinations are repeatedly developed & synthesised for the therapy for viral diseases. Consequently it requires new methods for the analysis and quality control testing for these new drugs. In the present method is for analysis of antiviral drugs cabotegravir CAB and rilpivirine RILP in pure api & Intramuscular Injection I.M injectable dosage forms. This method is optimised for analysis, of these two drugs in combined forms for rapid analysis with very less amount of analytes drugs utilized for testing purposes. The concentration range for the linearity is 2.5 to 15 μg/ml for CAB cabotegravir & for Rilpivirine RILP it is 3.75 to 22.5 μg/ml, which is very a smaller amount of drugs are utilised. 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 used in analysis of drugs in injection formulations individually & in combined forms. The Stability & forceddegradations studies are carried out in different stress conditions and the impurities & pure drugs, are efficiently detected by the developed HPLC method.