Development and Validation of Stability Indicating Method for Riociguat with Forced Degradation Studies Using LC-MS

Abstract

The aim of the present study was to develop a validated stability indicating reverse phase high performance liquid chromatography (RP-HPLC) method for estimation ofRiociguat, a pulmonary hypertension drug. An isocratic, RP-HPLC method was developed on Agilent Zorbax C18 (250 mm × 10 mm, 5 μm) analytical column using 0.1% Formic acid: methanol (20:80 v/v) as mobile phaseat flow rate of 1.0 ml/min at detection wavelength of 322 nm. The retention time of drug was 4.3 ± 0.328 min. The method was validated with respect to linearity, precision, accuracy and robustness. The data of linear regression analysis indicated a good linear relationship over the range of 2-12μg/ml concentrations with a correlation coefficient (R2) of 0.997. Riociguatwas subjected to different stress testing conditions and the degradation product was characterized using LC-MS technique. The developed method was found to be simple, sensitive, accurate, and precise for analysis of riociguat and can be adopted for routine analysis of drug in bulk and pharmaceutical dosage forms