VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF RILPIVIRINE AND DOLUTEGRAVIR IN BULK FORMAbstract
New simple, sensitive, and validated stability-indicating RP-HPLC method has been developed for the simultaneous estimation of Rilpivirine and Dolutegravir in its bulk form. Chromatographic separation was achieved on a Hypersil ODS (250mm × 4.6mm i.d., 5µm) maintained at ambient temperature by a mobile phase consisted of methanol and water (80:20v/v) and a flow rate of 1.0mL/min with a load of 20µL. The detection wavelength was set at 282nm. The retention time for the drugs was found to be Rilpivirine (5.14min), Dolutegravir (6.72min). The eluted compounds were detected using a UV detector. The drugs were subjected to stress degradation as per ICH Q1A. There was the interference of degradant at RT of Rilpivirine and Dolutegravir. The developed method was successfully validated according to ICH guidelines. The calibration curve was found to be linear over a range of 10-100µg/mL. The accuracy of the method is indicated by a good recovery in the range of Rilpivirine 99-102% and of Dolutegravir 99-102%. The limit of detection and limit of quantification of Rilpivirine was found to be LOD-0.844µg/mL and LOQ-2.557µg/mL, and for Dolutegravir was found to be LOD-0.082µg/mL and LOQ-0.249µg/mL.
K. S. Reddy *, S. S. Shirisha and K. P. Kumar
Pharmacognosy & Phytochemistry, Vaagdevi College of Pharmacy, Ramnagar, Hanamkonda, Warangal, Telangana, India.
23 July 2019
10 September 2020
19 September 2020
01 October 2020