ISSN : 2663-2187

STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF IMEGLIMIN HYDROCHLORIDE IN BULK AND PHARMACEUTICAL FORMULATION BY UV-SPECTROPHOTOMETER

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Uttam Prasad Panigrahy, Anupam Roy, Shayed Anowar Hussain, Kabya Pratim Das, Ananya Deka
» doi: 10.33472/AFJBS.6.11.2024.811-823

Abstract

Imeglimin Hydrochloride is an anti diabetic drug which blocks oxidative phosphorylation and inhibits hepatic gluconeogenesis, increase muscle glucose uptake, and restore normal insulin secretion. A rapid, simple, specific, and economic UV-spectrophotometric method has been developed to determine the stability indicating method for Imeglimin using distilled water as a solvent. The absorption spectrum of Imeglimin Hydrochloride showed maximum absorbance at 240nm and obeyed beer’s law in concentration range 1-16µg/ml. Linear regression of absorbance on concentration gave the equation y=0.059x+0.003 with correlation coefficient 0.999. The method developed is validated for parameters like specificity, linearity, range, accuracy, precision, LOD, LOQ, robustness as per Q2A specifications of the ICH guidelines. The drug sample was exposed to acid, alkali, and oxidation by hydrogen peroxide, thermal and photolytic conditions to study the forced degradation of the drug. The forced degradation studies, it was found that the drug Imeglimin Hydrochloride in the presence of degradation products. By the forced degradation studies, it was found that the drug Imeglimin Hydrochloride is maximum degraded in the presence of acid and peroxide degradation, moderately degraded in alkali and thermal degradation and mild degradation in photolytic degradation as per the studies performed. So, it was concluded that the drug should be stored in cool and dark place, away from acid, alkali and peroxide environment. The obtained results proved that this method can be employed for the routine analysis of Imeglimin Hydrochloride in bulk as well as in the commercial formulations.

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