Analytical Method Development and Validation of Etravirine by RP-UFLC

Abstract

An ultra-fast liquid chromatography (RP-UFLC) approach was processed for the estimation of ETR, which is quick, responsive, reliable, and inexpensive. Work on the Phenomenex Kinetex C18 column (250x 4,6mm. 5μ) was carried out with MeOH and acetonitrile in the mobile phase ratio of (60:40v/v) at 1.0mL/min. With a PDA detection system, the eluent was tracked at 311nm. ETR elutes at a persistence time of 3.226 min. The proposed method gives linearity of concentration from 1 to 5μg/mL, with the value of R2 at 0.9942%. For the proposed method, LOD and LOQ are measured as 0.02 and 0.073μg/mL. The pharmaceutical drug included acidic, alkaline, corrosion, Ultraviolet, and heat stress stipulations. The deterioration material was nicely resolved from ETR peaks, which showed the reliability of the process. The approach has been tested with respect to process adequacy, linearity, reliability, and robustness, as per ICH guidelines.