Abstract

DEVELOPMENT AND VALIDATION OF NOVEL DRUG-VERICIGUAT QUANTIFIED USING RP-HPLC-PDA METHOD

Nayela Ghazal*, K. Rambabu, D. Roopa, V. Karunakar, B. Sai Kumar, M. Vijay Kumar and Mohammed Shaker

ABSTRACT

A novel, rapid, and economical RP-HPLC method was developed for the determination of Vericiguat in API (Active Pharmaceutical Ingredient). The developed method was validated as per the ICH guidelines. An Inertsil - ODS C18 (250 x 4.6 mm, 5μ) column at ambient temperature and an eluent system with a Methanol: Acetonitrile (60:40) ratio were used for chromatographic separation. This separation condition showed symmetrical peaks with high resolution at a wavelength of 225 nm using PDA detection at a 1.0 ml/min flow rate and injection volume at 20 μL. Vericiguat showed linearity for the range of 20-70μg/mL with a correlation of determination R2=0.9999 and curve fitting (y=52296x + 6339). The accuracy was determined by recovery studies and was found in the range of 99.92-100.53% the results were within the acceptable limits for the method and the intermediate precision. RSD% of the determination of precision was ≤ 2%. The results for LOD and LOQ were 0.0047μg/mL and 0.01429 μg/mL respectively. The proposed method showed the results of system suitability, robustness, and ruggedness were within acceptable limits. It is noteworthy to state that so far, the literature survey revealed no analytical report on vericiguat. Hence reporting the first method for the development and validation of vericiguat using the RP-HPLC method.

Keywords: Acetonitrile, PDA detection, RP-HPLC, Vericiguat.