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ISSN 2063-5346
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Comprehensive Development and Validation of a RP-UPLC Method for the Determination of Flupirtine Maleate in Pharmaceutical Dosage Forms

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Kajal Singh, Shilpa Pahwa, Shivani
» doi: 10.53555/ecb/2022.11.12.152

Abstract

This research paper presents the development and validation of a rapid and efficient Reverse Phase Ultra-Performance Liquid Chromatography (RP-UPLC) method for the analysis of Flupirtine Maleate in a pharmaceutical dosage form. The chromatographic separation employs a high-pressure isocratic elution mode with specific column chemistry and a mobile phase composed of 0.05% TFA (pH 2.4) and acetonitrile in a 70:30 (v/v) ratio. Rigorous validation demonstrates high precision, accuracy, and specificity, meeting the requirements of the United States Pharmacopeia (USP) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The method's robustness is confirmed against minor variations, making it an invaluable asset for routine analysis in quality control laboratories, contributing to increased productivity and solvent conservation. This UPLC method offers significant advantages over standard HPLC techniques, benefiting both businesses and end-users in pharmaceutical quality control.

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