Abstract

DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR THE ESTIMATION OF VERICIGUAT IN TABLET DOSAGE FORM

Siddhi S. Bodke*, Komal V. Ujagare, Ashok Kumar, Vijay Kumar Munipalli, Sayali Warde, Sujata S. Kaisare and Dr. Naomita Dhume

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Abstract

A new, selective, precise and accurate RP-HPLC method was developed and validated for the estimation of Vericiguat in tablet dosage form. Riociguat was used as an Internal Standard(I.S). The chromatographic analysis was performed on Hemochrom C18 (250 mm × 4.6 mm, 5 μm) column with the mobile phase consisting of 0.1% Trifluoroacetic acid and Acetonitrile in the ratio of 65:35% v/v at the flow rate of 1 mL/min. The analyte was detected at the wavelength of 327 nm. The retention time of vericiguat was found to be 8.3 min. The method showed linear responses over the concentration range of 5- 150 μg/mL of vericiguat with a regression coefficient of 0.999. LOD and LOQ values were 6.6 μg/mL and 19.9 μg/mL respectively. The accuracy of the proposed method as determined by recovery studies was found to be 99.57%. The Percentage RSD of each parameter was found to be within the limit as per the ICH guidelines.

Keywords: RP-HPLC, Method development, Validation, Vericiguat, Riociguat, Internal Standard.