Author(s): Maruthi R, Chandan R.S, Anand Kumar Tengli

Email(s): rschandan@jssuni.edu.in

DOI: 10.5958/0974-360X.2021.00003.2   

Address: Maruthi R, Chandan R.S*, Anand Kumar Tengli
Department of Pharmaceutical Chemistry, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru - 570 015, (KA), India.
*Corresponding Author

Published In:   Volume - 14,      Issue - 1,     Year - 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 to amass and NMR analysis of LC-MS/MS was performed using a reverse-phase column of C18 and with a mobile step consisting of methanol and ammonium type in a ratio of 70:30 to pH 4.6. The injection volume is 10 µL, and the binary gradient system was used to isolate. The flux rate was maintained at 1.0 ml/min. The temperature of the column was held at 45oC. For this study, the MS conditions were adopted with a scan range of m/z= 50 to 500 with a dwell time of 3 seconds.


Cite this article:
Maruthi R, Chandan R.S, Anand Kumar Tengli. LC-MS/MS and NMR Characterization of impurities in Epalrestat. Research J. Pharm. and Tech. 2021; 14(1):11-13. doi: 10.5958/0974-360X.2021.00003.2

Cite(Electronic):
Maruthi R, Chandan R.S, Anand Kumar Tengli. LC-MS/MS and NMR Characterization of impurities in Epalrestat. Research J. Pharm. and Tech. 2021; 14(1):11-13. doi: 10.5958/0974-360X.2021.00003.2   Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-1-3


REFERENCES:
1.    Chaudhari KL, Maheshwari DG. RP-HPLC Method for the estimation of Epalrestat and Methylcobalamin in their combined dosage form. Indo. Am. J. Pharm. Res. 2014; 4:2697-705.
2.    Huang J, Sun R, Feng S, He J, Fei F, Gao H, Zhao Y, Zhang Y, Gu H, Aa J, Wang G. Sensitive analysis and pharmacokinetic study of epalrestat in C57BL/6J mice. Journal of Chromatography B. 2017; 1055:98-103.
3.    Nirogi R, Kandikere V, Ajjala DR, Bhyrapuneni G, Muddana NR. LC–MS/MS method for the quantification of aldose reductase inhibitor–Epalrestat and application to pharmacokinetic study. Journal of Pharmaceutical and Biomedical Analysis. 2013; 74:227-34.
4.    Parameswari SA, Arunamma G. Stability indicating RP-HPLC method for simultaneous determination of Epalrestat and Pregabalin in bulk and tablet dosage form. International J Pharmaceutical SCIENCES AND Research. 2018; 9 (5):1844-50.
5.    Parsha S, Kumar YR, Ravichander M. LC–MS/MS and NMR characterization of key impurities in linagliptin and pramipexole. Journal of Liquid Chromatography and Related Technologies. 2015; 38(19):1699-712.
6.    Pathi PJ, Raju NA. The estimation of Epalrestat in Tablet dosage form by RP-HPLC. Asian Journal of Pharmaceutical Analysis. 2012; 2(2):49-51.
7.    Sun H, Bo Y, Zhang M, Wu X, Zhou M, Zhao L, Xiong Z. Simultaneous determination of epalrestat and puerarin in rat plasma by UHPLC–MS/MS: Application to their pharmacokinetic interaction study. Biomedical Chromatography. 2017; 31(4):e3855.
8.    Okamoto H, Nomura M, Nakaya Y, Uehara K, Saito K, Kimura M, Chikamori K, Ito S. Effects of epalrestat, an aldose reductase inhibitor, on diabetic neuropathy and gastroparesis. Internal Medicine. 2003;42(8):655-64.
9.    Saraf M, Birajdar P, Loya P, Mukherjee S. Rapid and sensitive HPTLC method for determination of epalrestat in human plasma. JPC-Journal of Planar Chromatography-Modern TLC. 2007 Jun 1;20(3):203-7.
10.    Ohmura C, Watada H, Azuma K, Shimizu T, Kanazawa A, Ikeda F, Yoshihara T, Fujitani Y, Hirose T, Tanaka Y, Kawamori R. Aldose reductase inhibitor, epalrestat, reduces lipid hydroperoxides in type 2 diabetes. Endocrine Journal. 2008:0810310204-.

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