Friday , 23 February 2024

Stability Indicating RP-HPLC Method for Simultaneous Estimation of Dolutegravir and Rilpivirine in Its Pure and Pharmaceutical Dosage Form

Sonalika Patro1, Ramesh Dhani1*, V. Haribaskar1, K. Sivasankar2
1Department of Pharmaceutical Analysis, Ratnam Institute of Pharmacy, Nellore, Andhra Pradesh

2Department of Chemical Engineering, SVU University, Tirupathi, Andhra Pradesh

A Simple Rapid, Precise and Accurate High Performance Liquid Chromatography method was Developed and Validated for Determination of Dolutegravir and Rilpivirine in Bulk and Pharmaceutical Dosage Form. The Method Development was carried out by using INERTSIL ODS column (200×4.6mm, 5µm), using a mixture of 0.1% OPA : Acetonitrile in the ratio of (80 : 20) as mobile phase. The flow rate is 1.5ml/min, with a detection wavelength of 230nm. The retention time of Dolutegravir was found to be 3.4 min and Rilpivirine was 4.3 min. The percentage purity of Dolutegravir and Rilpivirine was found to be 100.08% and 99.4% respectively. The system sutability parameters such as theoretical plate and tailing factor for Dolutegravir and Rilpivirine was found to be 2657, 1.42 and 3669, 1.40 respectively. The resolution of both the drugs was found to be 3.52. The analytical method was validated according to ICH guidelines (ICH, Q2, (R1)).  The method was found to be linear in the concentration ranges of 50µg – 250µg for Dolutegravir and 25µg – 125µg for Rilpivirine and correlation coefficient (r2) value was found to be 0.999 and 0.999, percentage RSD for repeatability was found to be 0.3 and 0.8, percentage RSD for intermediate precision was 0.3 and 0.4 respectively. The precision study was precise, robust, and repeatable. The LOD values are 3.08 and 3.0 and LOQ values are 10.10 and 10.02 respectively. Hence the suggested RP-HPLC method can be used for routine analysis of Dolutegravir and Rilpivirine in API and Pharmaceutical Dosage Form.
Keywords: Inertsil ODS column, Dolutegravir and Rilpivirine, RP-HPLC, precision, API, Pharmaceutical Dosage Form.

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