World Journal of
Pharmaceutical and Life Sciences

METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF ELBASVIR AND GRAZOPREVIR BY RP-HPLC

*G. Edward Raju, BH. Sriswetha, M. Shiny, K. Nageswara Rao and D. Raghava

ABSTRACT

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 Xterra C18 5µm (4.6*250mm) column, flow rate was 1ml/min, mobile phase ratio was Phosphate buffer (0.05M) pH 4.6: ACN (55:45%v/v) (pH was adjusted with orthophosphoric acid), detection wave length was 255nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, PDA Detector 996, Empower-software version-2. The retention times were found to be 2.399 mins and 3.907 mins. The % purity of Elbasvir and Grazoprevir was found to be 99.94% and 99.95% respectively. The system suitability parameters for Elbasvir and Grazoprevir such as theoretical plates and tailing factor were found to be 1.3, 4668.7 and 1.3, 6090.3 the resolution was found to be 2.4. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study for Elbasvir and Grazoprevir was found in concentration range of 1?g-5?g and 100?g-500?g and correlation coefficient (r2) was found to be 0.999 and 0.999, % mean recovery was found to be 100.4% and 100.5%, %RSD for repeatability was 0.7 and 0.4, % RSD for intermediate precision was 0.18 and 0.39 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. Hence the suggested RP-HPLC method can be used for routine analysis of Elbasvir and Grazoprevir in API and Pharmaceutical dosage form.

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