.

ISSN 2063-5346
For urgent queries please contact : +918130348310

DESIGN AND VALIDATION OF AN IDEAL RP-HPLC METHOD FOR EVALUATION OF NICOUMALONE IN BULK DRUG AND TABLET FORMULATION

Main Article Content

Jayshreemaa Biswal , Nihar Ranjan Kar, Bisakha Tripathy , Saroj Kanta Bisoyi , Asit Baran Panigrahy
» doi: 10.48047/ecb/2023.12.si8.332

Abstract

The goal of this research aims to accomplish the efficacy of Nicoumalone through the utilization of an isocratic RP-HPLC (Reverse Phase High Performance Liquid Chromatography) method in both bulk and tablet formulation. Quantification was performed using a Phenomenex Luna C18, 100A0 , 5µm, 250mm X4.6mm column. Various solvents were evaluated at varying proportions to determine the optimal outcome for the development of the system. The analysis revealed that Acetonitrile: Methanol (35:65 % V/V) is a suitable solvent for use as the mobile phase. The separation was conducted at room temperature using UV detectors to a specific value that has been established at 285 nm, at a flow rate of 1 millilitre per minute. The compound Nicoumalone exhibited a retention time of 4.07 minutes, which appears to be superior to that of other compounds. The recommended method is deemed validated in accordance with the regulations set forth by the International Conference of Harmonization (ICH). Several analytical parameters go through statistical validation, including precision, reliability, and limits of quantization, limit of detection, the concept of linearity and others. The proposed method is deemed useful for achieving optimal precision in the analysis of dosage forms of drugs and their formulations.

Article Details