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Isolation, characterization and cumulative quantification approach for nine organic impurities in empagliflozin and linagliptin drugs

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Title Isolation, characterization and cumulative quantification approach for nine organic impurities in empagliflozin and linagliptin drugs
 
Creator Shah, Tusharkumar
Kapadiya, Khushal
Dhalani, Jayesh
 
Subject Empagliflozin
Force degradation
HPLC
Impurity
Linagliptin
 
Description 470-482
The aim of the study is to identify impurities in empagliflozin and linagliptin by using 1H & 13C NMR, LC-MS,
preparative, and analytical HPLC. To identify and quantify contaminants, a novel HPLC method has been validated. A
gradient programme has been used to separate four linagliptin impurities and five empagliflozin impurities, process-related
and degradation impurities that produced under stress, on the ACE PFP C18 column. Mobile phase A is acetonitrile and
0.1% orthophosphoric acid. As the mobile phase B, methanol and acetonitrile are combined in a 10:90%v/v. Pump flow is
adjusted to 1.0 mL/ min and 230 nm wavelength was chosen at 40 °C column oven temperature. During stress conditions,
acid, humid, base, ultraviolet light, thermal, and oxidative processes are carried out. The separation is achieved between the
peaks and degradation products. The method is validated with respect to current ICH guidelines for solution stability,
specificity, linearity, precision, accuracy, and robustness. Preparative HPLC is used to isolate two unknown impurities,
which were then identified using LC-MS, 1H & 13C NMR, based on literature, This is the first research study to propose nine
impurities in mixed dosage forms of empagliflozin and linagliptin with quantitative method.
 
Date 2024-05-07T09:57:06Z
2024-05-07T09:57:06Z
2024-05
 
Type Article
 
Identifier 0975-0991 (Online); 0971-457X (Print)
http://nopr.niscpr.res.in/handle/123456789/63866
https://doi.org/10.56042/ijct.v31i3.4234
 
Language en
 
Publisher NIScPR-CSIR, India
 
Source IJCT Vol.31(3) [May 2024]