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Published March 17, 2023 | Version v1
Journal article Open

DEVELOPMENT AND VALIDATION OF A RP - HPLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF TRANEXAMIC ACID AND MEFENAMIC ACID IN PURE AND PHARMACEUTICAL DOSAGE FORM

Description

A simple, Accurate, precise method was developed for the simultaneous estimation of the Tranexamic acid and Mefenamic acid in bulk and tablet dosage form. The chromatography was performed on a Waters 2695 HPLC system, equipped with an auto sampler, UV detector and Empower 2 software. Analysis was carried out at 282 nm with column Inertsil C18 (4.6mm ×250mm, 5µm particle size), dimensions at 350C temperature. The optimized mobile phase consists of Phosphate Buffer (pH-4.8): Methanol (55:45% v/v). Flow rate was maintained at 1 ml/min. Run time was selected to be 6 min because analyze gave peak around 1.688, 3.282 ±0.02min respectively and also to reduce the total run time. The percent recovery was found to be 98.0-102% was linear and precise over the same range. Both system and method precision was found to be accurate and well within range.   The analytical method was found linearity over the range 100-500mg/ml of Tranexamic acid and 30-70mg/ml of Mefenamic acid of the target concentration. The analytical passed both robustness and ruggedness tests. On both cases, relative standard deviation was well satisfactory.

Keywords: Tranexamic acid, Mefenamic acid, RPHPLC, Simultaneous estimation.

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