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RESEARCH JOURNAL OF PHARMACY AND TECHNOLOGY
Year : 2021, Volume : 14, Issue : 1
First page : ( 11) Last page : ( 13)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2021.00003.2

LC-MS/MS and NMR characterization of impurities in Epalrestat

Maruthi R, Chandan R.S.*, Tengli Anand Kumar

Department of Pharmaceutical Chemistry, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru-570 015, (KA), India

*Corresponding Author E-mail: rschandan@jssuni.edu.in

Online published on 22 April, 2021.

Abstract

For the identification and characterization of main impurities in Epalrestat, a responsive and rapid analysis of LC-MS/MS and NMR was created. Epalrestat is used in diabetic neuropathy therapy, which in patients with diabetes mellitus is one of the most severe long-term complications. Epalrestat is a derivative of carboxylic acid and a non-competitive and reversible inhibitor of the reductase of the aldose. It reduces intercellular sorbitol deposition that is thought to be causing diabetic neuropathy, retinopathy, and nephropathy. Aldose reductase is the key enzyme in the polyol pathway, the enhanced activity of which is the basis for diabetic neuropathy this enzyme is targeted by the aldose reductase inhibitors (ARI). Epalrestat is the only commercially available API. It is easily absorbed in the neutral tissues and has minimal side effects inhibiting the enzyme. At 5.1 RT in Epalrestat, one of the primary impurities was observed in the analytical HPLC process. Preparative HPLC technique was used to further characterize the impurity. To predict the structure, isolated impurity was subjected m/z= 50 to 500 with a dwell time of 3 seconds.

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Keywords

LC-MS/MS, NMR, HPLC, Epalrestat, Diabetic.

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