Determination of empagliflozin in the presence of its organic impurities and identification of two degradation products using UHPLC-QTOF/MS

A simple and fast analytical method with a low limit of quantification was developed and validated to determine EMPA and its synthetic impurities using UHPLC-QTOF-MS. The method was established using UHPLC equipment (Shimadzu-Nexera x2), Zorbax Eclipse Plus C18 column (2.1 x 50 mm, 1.8 mu m), injection volume of 5 mu L and constant temperature of 35 degrees C. Parameters investigated for method validation, such as specificity, linearity, precision and accuracy, presented results within the acceptable range. In addition, the formation of two degradation products, different from the impurities studied, was observed when EMPA was exposed to UVC light for 24 h and 2 M NaOH for 48 h. These molecules were identified contributing to the knowledge of the EMPA impurity profile.

Automated summary

A simple and fast analytical method was developed and validated to determine EMPA and its synthetic impurities using UHPLC-QTOF-MS, with parameters such as specificity, linearity, precision, and accuracy within acceptable ranges. Additionally, two new degradation products were observed under exposure conditions, contributing to the understanding of the EMPA impurity profile.