Abstract
STABILITY INDICATING HPLC METHOD FOR THE QUANTIFICATION OF (R)- ISOMER IN EMPAGLIFLOZIN DRUG SUBSTANCE

Vijaya Gouri Korlakunta* Sreenivas N., Hemant Kumar Sharma, Annapurna Nowduri,
Kishore Babu Bonige and Ramadas Chavakula

ABSTRACT

A simple sensitive isocratic normal phase chiral HPLC Method was developed for the chiral purity of Empagliflozin, a new anti-diabetic drug substance. The enantiomers of Empagliflozin and its (R)-enantiomer were resolved on new immobilized cellulose tris (3,5- dichlorophenyl carbamate) stationary phase, Chiralpak IC column using a mobile phase consisting of n-Hexane: Isopropyl alcohol : ethanol: Methyl tert- butyl ether and trifluoro acetic acid in the ratio of (650:200:100:50:1 v/v/v/v) at 25 °C column oven temperature with the flow rate of 1.0 mL min-1 and detection on UV/VIS detector wavelength at 224 nm. The USP resolution between both the Enantiomers was not less than 1.5 in this method. Limit of detection (LOD) and Limit of Quantitation (LOQ) for (R)-Empagliflozin were 0.01 %w/w and 0.030%w/w respectively. The accuracy of the method was in the range of 90.5 to 95.9%. The developed method was validated as per International Conference on Harmonisation (ICH) guidelines in terms of Specificity, Limit of detection (LOD), Limit of Quantitation (LOQ), Precision, Linearity, Accuracy, Solution stability and Robustness. This method is useful to control the enantiomeric impurity in routine use.

Keywords: Empagliflozin; HPLC method; Chiral method; (R)-Isomer; Method Validation.


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