Abstract

STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF RIOCIGUAT IN BULK & PHARMACEUTICAL DOSAGE FORM

Sanika A. Dichwalkar* and Dr. Purnima D. Hamrapurkar

Abstract

The Paper involves Development of a simple, precise and stabilityindicating Reverse Phase High Performance liquid chromatographic method for determination of Riociguat in Bulk as well as in Marketed formulation, using an Inertsil ODS-3 C18 column with a mobile phase composed of Buffer: ACN (50:50, v/v), pH 4.5, adjusted using glacial acetic acid with a run time of 15 mins and wavelength for Estimation at 323nm using PDA Detector. The Retention time for Riociguat was found to be at 5.6 mins. Linearity for Riociguat was established in the range of 1.00-3.00 μg/ml having correlation coefficient R2 value as 0.9999. The Accuracy was found to be in the range of 98.00% - 102.00%. Forced Degradation studies revealed that the method developed to be stability-indicating. The results Obtained showed that the proposed method is suitable for the precise determination of Riociguat in bulk and its formulation.

Keywords: Riociguat, HPLC, Development and Validation, Stability Indicating Method.