Development and Validation of Stability-Indicating UPLC-TUV Method for Simultaneous Estimation of Darunavir and Ritonavir in Bulk and Tablet Dosage Form

Abstract

A straightforward, explicit, accurate and monetary ultra-performance liquid chromatographic with tunable ultraviolet indicator (UPLC-TUV) strategy was produced for the simultaneous estimation of Darunavir and Ritonavir in bulk and tablet dosage form. The Separation was accomplished on a BEH C18 section (4.6 mm X 50 mm, 5 µm) at a frequency of 270 nm, utilizing a mobile phase acetonitrile and water (50:50 V/V) in an isocratic elution mode at a stream pace of 0.3 mL/min. The maintenance time for Darunavir and Ritonavir was discovered to be 0.739 min and 0.401 min, individually. The proposed strategy was validated for precision, linearity range, accuracy, roughness, and constrained degradation concentrates according to ICH rules. The adjustment bends of Darunavir and Ritonavir were linear over the scope of 100-600 µg/mL and 12.5 to 75 µg/mL. The LOD’s were discovered to be 1.93 and 0.03 for Darunavir and Ritonavir, separately. The LOQ’s were discovered to be 5.84 for Darunavir and 0.08 for Ritonavir. The strategy was discovered to be precise and stability-showing has no meddling pinnacles of debases and excipient were noticed. The created technique was appropriate for quality control labs for quantitative examination of both in bulk and joined dose structure. The created strategy is new and better in innovation when contrasted than the announced techniques and less maintenance time, high theoretical plate check and structure of the mobile phase with great division, precise and stability-showing has no meddling pinnacles of debases and excipient were noticed. The technique was appropriate for quality-control research centers for quantitative examination of both in bulk and consolidated measurements structure.