DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF DOLUTEGRAVIR AND RILPIVIRINE BY FORCED DEGRADATION STUDIESAbstract
Background: Dolutegravir and Rilpivirine are two antiretroviral drugs that have been approved for the treatment of HIV Infection. An error-free, accurate, precise and valid reverse-phase liquid chromatography method was developed for the quantitation of Dolutegravir and Rilpivirine in its bulk form as well as in combined dosage form by forced degradation studies. Methods: Chromatographic separation of these two drugs Dolutegravir and Rilpivirine, was achieved with an INERTSIL ODS C18 (250 × 4.6 mm, 5 μm) reverse-phase analytical column with a 10 min analytical run time using a mixture of 0.1% OPA: Acetonitrile in the ratio of (60:40 v/v) as mobile phase. The mobile phase was streamed at a flow rate of 1.0 mL min-1 with a column temperature of 250 °C and detection wavelength was carried out at 230 nm. The retention time was found to be 3.4 min for Dolutegravir and 4.3 min for Rilpivirine. Results: The linearity limit of Dolutegravir and Rilpivirine was found to be in the range of 0.999 and 0.999. The method validation was carried out in terms of accuracy, linearity, precision, specificity, LOD, LOQ as per ICH Guidelines. Conclusion: The results obtained from the validation parameters show that the method developed can be useful in the quality control test of bulk and combined dosage forms of Dolutegravir and Rilpivirine. Dolutegravir and Rilpivirine were exposed to different stress conditions like acidic, basic, neutral, thermal and peroxide. Amongst all, the drug was found to be more degraded under thermal as well as photodegradation conditions.
M. Niranjan Babu * and R. Chandrasekar
Department of Pharmacognosy, Seven Hills College of Pharmacy, Tirupati, Chittoor, AP. India.
23 September 2020
12 March 2021
24 May 2021
01 September 2021