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Analytical method development and validation for the estimation of Rilpivirine and its N-Oxide impurity using UPLC Soujanya Varada, Nalanda Revu Baby* Department of Pharmaceutical Analysis, GITAM School of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, India *Corresponding Author E-mail: nrevu@gitam.edu
Online Published on 07 February, 2024. Abstract Rilpivirine is used to treat human immunodeficiency virus type 1 (HIV-1). A new stability indicating RP-UPLC method has been developed for the estimation of Rilpivirine and N-Oxide impurity using Waters UPLC Aqcuity SYSTEM with TUV detector integrated with Empower 2 Software with Kromasil (250 × 4.6 mm, 5μm) C18 column (PDA detector) was used for the present study. A mixture of 0.1% ortho phosphoric acid solution and methanol (50: 50, v/v) was used as the mobile phase for the chromatographic study (Flow rate: 1.0 ml/min; Detection wavelength: 279 nm). Stress degradation studies were performed and the method was validated as per ICH guidelines. Top Keywords Rilpivirine, RP-UPLC, N-Oxide, Stability indicating, Validation, ICH guidelines. Top | |
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