Inherent stability testing of empagliflozin in the presence of metformin HCl by HPTLC and characterization of degradation products of empagliflozin by LC–ESI–QTOF–MS/MS

Metabolism and Chemical Degradation of New Antidiabetic Drugs: A Review of Analytical Approaches for Analysis of Glutides and Gliflozins

“…In the study of Vichare et al [ 49 ], the stability of EMPA in the presence of metformin was examined using high performance thin-layer chromatography (HPTLC). A system with pre-coated silica gel plates, a twin-trough chamber, and a TLC Scanner were used.…”

“…By analyzing the obtained spectra, the substitution of the chlorine atom by the OH group was proposed. Under oxidative conditions, EMPA was found to generate one more degradant, i.e., EMPA-D5 ( Figure 12 ), that could be formed by oxidation of the primary alcoholic group to carboxylic acid to form 6-(4-chloro-3{[4-(oxalan-3-yloxy)phenyl]methyl}phenyl)-3,4,5-trihydroxyoxane-2-carboxylic acid [ 49 ].…”

“… Degradation pathways of empagliflozin (EMPA) in alkaline, oxidative and photolytic conditions; for EMPA-D15 and EMPA-D16 m / z [M+NH 4 ] + [ 32 , 33 , 49 ]. …”

“…Various Tox21-Nuclear receptor signaling pathways, Tox21-stress response pathways, and toxicity targets were included in this study. Prediction tools identified that In the study of Vichare et al [49], the stability of EMPA in the presence of metformin was examined using high performance thin-layer chromatography (HPTLC). A system with pre-coated silica gel plates, a twin-trough chamber, and a TLC Scanner were used.…”

“…The LC-UV method suitable for elucidating degradation of EMPA was also proposed by Niguram et al [33] using a Kromasil 100 C18 column from Merck and UV detection at 226 nm (Table 1). The sum of degradants generated during accelerated degradation was [32,33,49].…”