Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF DOLUTEGRAVIR AND RILPIVIRINE BY RP-HPLC METHOD

*Yaparalla Nagarjuna Reddy, Kotammagari Swathi, Shaik Rahamathi, G. Venkata Sowmya Sree and Kolavali Yalla Reddy

ABSTRACT

A New and Simple Rapid, Precise, and Accurate High-Performance Liquid Chromatography method was successfully Developed and Validated for the Determination of Dolutegravir and Rilpivirine in Bulk and Pharmaceutical Dosage Form. The Method Development was carried out by using Discovery, C18 (200 x 4.6mm, 5μm), using a mixture of 0.1% OPA: Acetonitrile in the ratio of (60: 40) as mobile phase. The flow rate is 1.0 ml/min, with a detection wavelength of 230 nm. The retention time of Dolutegravir was found to be 3.41 minutes and Rilpivirine was 4.38 minutes. The system suitability parameters like the theoretical plate and tailing factor for Dolutegravir and Rilpivirine were found to be 2656, 1.43 and 3668, 1.39 respectively. The resolution of both drugs was found is 3.52. The analytical method was validated according to ICH guidelines (ICH, Q2). The method was found to be linear in the concentration ranges of 50 μg – 250 μg for Dolutegravir and 25 μg – 125 μg for Rilpivirine and correlation coefficient value was found to be 0.999 and 0.999, %RSD for repeatability was found to be 0.3 and 0.8, % RSD for intermediate precision was 0.3 and 0.4 respectively. The precision study was precise, robust, and repeatable. The Limit of Detection values are 3.07 and 3.01 and the Limit of Quantification values are 10.10 and 10.02 respectively. Hence the suggested RP-HPLC system can be used for routine analysis of Dolutegravir and Rilpivirine in API and Pharmaceutical Dosage Form.

Keywords: Dolutegravir, Rilpivirine, HPLC, Precision, Linearity etc.