A NOVEL STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ANTI-VIRAL CLASS OF ELBASVIR AND GRAZOPREVIR IN BULK AND PHARMACEUTICAL DOSAGE FORM

Objective: To develop accurate, precise stability indicating a method for simultaneous estimation of Elbasvir and Grazoprevir in bulk and pharmaceutical dosage form. Materials and Methods: Simple, rapid, precise, sensitive and reproducible validated stability-indicating Reverse-Phase High-Performance Liquid Chromatography (RP-HPLC) method for the quantitative analysis of Elbasvir and Grazoprevir in the pharmaceutical dosage form. Chromatographic separation was carried out on waters Alliance-2695, by using Luna C18 (150 mm × 4.6 mm, 5 µm) column and the mobile phase containing OPA buffer (0.1%) and acetonitrile in the ratio of 50:50 v/v. The flow rate was 1.0 ml/min; detection was carried out at 258 nm using a photodiode array detector at ambient temperature. Results: The number of theoretical plates and tailing factor for Elbasvir and Grazoprevir were obtained to be NLT 2000 and should not more than 2 respectively. The linearity of the method was excellent over the concentration range 1.53-22.95 µg/ml and 3.05-45.75 µg/ml for Elbasvir and Grazoprevir respectively. The correlation coefficient was 0.999%. The relative standard deviation of peak areas of all measurements was less than 2.0. The proposed method was validated according to ICH guidelines. Conclusion: The method was found to be a simple, economical, suitable, precise, accurate and robust method for quantitative analysis of Elbasvir and Grazoprevir in combination and its stability.