Abstract

DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR ESTIMATION OF VERICIGUAT IN TABLET DOSAGE FORM

Anuja Varadkar*, Shivani Patankar, Bhushan Sonawane, Vijay Kumar Munipalli, S. U. Warde, Raman Mohan Singh and Dr. Naomita Dhume

ABSTRACT

A simple, suitable and precise High Performance Thin Layer Chromatography (HPTLC) method was developed and validated for the estimation of Vericiguat in its tablet dosage form. The method was developed on Silica gel 60 F254 HPTLC plates and the mobile phase used was Hexane: Ethanol: Ethyl acetate: Glacial acetic acid in the ratio of (6:2:2:0.05 V/V/V/V). Densitometric scanning and quantification were carried out at a wavelength of 327nm. The Retention Factor (RF) value for Vericiguat was found to be 0.704. The method was validated as per the ICH guidelines for parameters such as specificity, linearity, precision, recovery, sensitivity and robustness. The method was found to be linear in the concentration range of 50-200ng/band with a correlation coefficient value of 0.9993. The mean percentage recovery of Vericiguat was found to be 100.54%. The Limit of Detection (LOD) and Limit of Quantification (LOQ) values for Vericiguat was found to be 8.62 and 26.14 respectively. The method is novel as no other HPTLC method was reported before for the estimation of Vericiguat in the tablet dosage form.

Keywords: High Performance Thin Layer Chromatography (HPTLC), Silica gel 60 F254 HPTLC plates, Vericiguat, CAMAG Linomat 5, CAMAG visionCATS, 327nm wavelength, Method Development, Method Validation.