Analytical Method Development and Validation for the Simultaneous Estimation of Elvitegravir and Cobicistat by RP-HPLC Method

Abstract

A new method was established for simultaneous estimation of Elvetigravir and Cobicistat by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Elvetigravir and Cobicistat by using Xterra C18 5 µm (4.6×150 mm) column, flow rate was 1 ml/min, mobile phase ratio was phosphate buffer (0.05 M) pH 7: MEOH (30:70%v/v) (pH was adjusted with orthophosphoric acid), and the detection wave length was 270 nm. The instrument used was WATERS HPLC Auto Sampler, separation module 2695, PDA detector 996, and Empower-software version-2. The retention times were found to be 2.399 and 3.907 min. The % purity of Elvetigravir and Cobicistat was found to be 100.7 and 101.4% respectively. The system suitability parameters for Elvetigravir and Cobicistat such as theoretical plates and tailing factor were found to be 1.3, 5117.5 and 1.4, 3877.3; and the resolution was found to be 8.0. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study for Elvetigravir and Cobicistat was found in concentration range of 10–50 μg and 20–100 μg and correlation coefficient (r2) was found to be 0.997 and 0.997, %mean recovery was found to be 100 and 100.5%, %RSD for repeatability was 0.2 and 0.4, %RSD for intermediate precision was 0.5 and 0.1 respectively. The precision study was precise, robust, and repeatable. LOD value was 2.95 and 3.04, and LOQ value was 9.87 and 10 respectively. The present work is aimed to develop a new, simple, fast, rapid, accurate, efficient and reproducible RP-HPLC method for the simultaneous analysis of Elvetigravir and Cobicistat in API and pharmaceutical dosage form.

Keywords: Elvetigravir, Cobicistat, buffer, methanol

Cite this Article

Rajashakar V, Godasu SK, Chinna Eswaraiah M. Analytical Method Development and Validation for the Simultaneous Estimation of Elvitegravir and Cobicistat by RP-HPLC Method. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2018; 5(2): 1–6p.