Method Development and Validation for the Quantitative Determination of Vericiguat in Bulk Form and Marketed Pharmaceutical Dosage Forms by using RP-HPLC (Research Article)

Author(s): Chennupati V Suresh*, J. Rajeshwari, Santhosh Illendula, K N Venkateswara Rao

Abstract: The aim of the present study is to develop simple, precise, and accurate methods for quantitative estimation of Vericiguat in bulk form and marketed pharmaceutical tablet dosage form. The method was achieved on Symmetry C18 ODS (4.6mm×250mm) 5μm particle size column with mobile phase containing composition of Acetonitrile and Phosphate buffer (0.01M, pH-3.2) in the ratio of 30:70v/v at a flow rate 1.0ml/min with detection wavelength at 246nm. The linearity was obtained in the concentration range of 6-14 μg/ml for Vericiguat. The suitability of this method was proved by validation in accordance with ICH Q2 (R1) guidelines. The method was found to be accurate with percent recovery was found to be 100.130%. The %RSD for method repeatability and for intermediate precision were found be within the limits i.e. 0.441, 0.258 and 0.373 respectively. The proposed method was found to be simple and sensitive for routine quality control application of Vericiguat used in bulk form and pharmaceutical tablet dosage form.

PAGES: 89-98  |  266 VIEWS  160 DOWNLOADS