Author(s): N. MD. Akram, M. Umamahesh, T. Ramachari
A New method was established for simultaneous estimation of Elbasvir and Grazoprevir by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Elbasvir and Grazoprevir by using Inertsil ODS column (4.6×250mm) 5μ, flow rate was 1ml/min, mobile phase ratio (40:60 v/v) Acetonitrile (CAN), phosphate buffer (KH2PO4) of pH 3 (pH adjusted with orthophosphoric acid), detection wavelength used by Waters HPLC Auto Sampler, Separation module 2695, UV detector 2489, Empower-software version-2. The retention times were found to be 2.841 mins and 4.337 mins. The % purity of Elbasvir and Grazoprevir were found to be 100.12 and 99.93 respectively. The present analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Elbasvir and Grazoprevir was found in the concentration range 100μg/ml-500μg/ml and 200μg/ml -1000μg/ml and correlation coefficient (R2) be 0.999 and 0.999, % recovery was found to be 100.11 and 100.38, %RSD for repeatability 0.5 and 0.1, % RSD for intermediate precision was 0.6 and 0.2 respectively. The precision study was precision, robustness and repeatability. It is a convenient, simple and quick method for the determination of Elbasvir and Grazoprevir in its bulk and pharmaceutical dosage forms.