DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF VERICIGUAT IN MARKETED FORMULATION

Abstract

For the estimation of Vericiguat in the API and Marketed formulation, Following ICH criteria, an accurate, precise, specific, and robust stability indicating RP-HPLC technique was designed and validated. The development of method utilized by Zorbax eclipse plus C18 (250 mm × 4.6mm × 5μm) column with mobile phase of 10mM Potassium dihydrogen phosphate: Methanol (60:40 v/v) in isocratic mode. The flow rate kept at 1.0 mL/min at 256 nm wavelength. Vericiguat has retention time 6.9 min. Developed method to be validated according to ICH guideline in term of linearity, Accuracy, Precision, Robustness, and Forced degradation studies was performed. Linearity was achieved with a correlation coefficient was 0.9995 between the concentration 50 μg/mL to 150 μg/mL. Percentage recovery was discovered within the limits of 98% to 102%. %RSD was found to be less than 2% which is the specified in range. Studies of forced degradation reveal that Acid and Alkali have the highest rates of degradation. Impurity peak eluted at 3.1 and 3.0 mins in Acid and Alkali degradation respectively. Vericiguat did not degrade in Thermal and Photolytic degradation.