DEVELOPMENT AND VALIDATION OF STABILITY INDICATING METHOD FOR THE SIMULTANEOUS ESTIMATION OF ELBASVIR AND GRAZOPREVIRIN PHARMA-CEUTICAL DOSAGE FORMS BY RP-HPLCAbstract
The present study aimed to develop and validate stability indicating method for the simultaneous determination of Elbasvir and Grazoprevir in its pharmaceutical dosage form using RP-HPLC. Chromatographic separation was done with Discovery C18 (250 mm × 4.6 mm, 5 µ) column using 0.1% ortho-phosphoric acid (OPA) and acetonitrile in the ratio 50:50% v/v as mobile phase on isocratic mode. The column oven temperature was maintained at 30 ºC with a flow rate 1.0 ml/min and components were detected at a wavelength of 315 nm. The retention times for Elbasvir and Grazoprevir was found to be 2.24 min and 3.21 min respectively. The developed method was validated according to ICH guidelines. A good linearity response was observed in the concentration range of 12.5 µg/ml – 75 µg/ml for Elbasvir and 25 µg/ml – 150 µg/ml for Grazoprevir with correlation coefficient of 0.999 for both the drugs. The method was found to be accurate, precise, specific, rugged and robust. The drugs were subjected to stress conditions for testing their stability and found to be stable, with net degradation was within the limits.
G. Ashok * and S. Mondal
Department of Pharmaceutical Analysis and Quality Assurance, Faculty of Pharmacy, Gland Institute of Pharmaceutical Sciences, Kothapet, Medak, Telangana, India.
27 September, 2017
18 December, 2017
25 December, 2017
01 July, 2018