Method development and validation for the simultaneous estimation of Doultegravir and Rilpivirine related impurities (Rilpivirine Z Isomer and Dolutegravir hydroxy impurity) using RP HPLC

Abstract

The combination of Doultegravir and Rilpivirine is used to treat human immunodeficiency (HIV) virus. A new stability indicating RP-HPLC method has been proposed for the quantification of Doultegravir and Rilpivirine along with its impurities Rilpivirine Z Isomer and Doultegravir hydroxy impurity using Water HPLC System (PDA detector) and auto sampler integrated with Empower 2 Software with Inertsil (250 × 4.6 mm, 5 μ) C18 column (PDA detector) was used for the present study. A mixture of 0.01N phosphate buffer and acetonitrile (50: 50, v/v) (pH adjusted to 4.8 with TEA and ortho phosphoric acid) was used as mobile phase for the chromatographic study (Flow rate: 1.0 ml/min; Injection volume: 10 μl; Detection wavelength: 257 nm) with run time 12 mins. Stress degradation studies were performed and the method was validated as per ICH guidelines. The developed method was found to be precise, specific, accurate, linear, stable and robust for the quantification of Dolutegravir and Rilpivirine along with its impurities Rilpivirine Z Isomer and Dolutegravir hydroxy impurity and its bulk drug formulation. The developed method can be applied successfully to quality control and for other analytical purposes.