Canagliflozin is a newly approved drug for type II diabetes mellitus. A full stability study of canagliflozin was performed following international conference on harmonization strategies. The drug was stable against all conditions except oxidation where only one degradation product was separated and structurally elucidated using mass spectrometry and infrared spectroscopy. A green high-performance thin-layer chromatographic densitometric determination was developed and validated for the accurate quantification of canagliflozin and its main oxidative degradation product. Separation was performed on high-performance aluminum plates precoated with silica gel using acetone/ethanol (80:20, v/v) as a developing system and scanning at 290 nm. Retardation factor values were 0.64 and 0.81 and linearity ranges were 0.4-3.6 and 0.2-3.2 μg/band for the drug and the degradation product, respectively. It was a matter of interest to use green solvents with no harmful effects on the environment. The comparison between the proposed and the reported high-performance liquid chromatography method regarding greenness profile showed that the proposed method was greener and so could be used as an alternative method to the reported one with no environmental harm. Method validity was tested as per international conference on harmonization and method utility was verified by application to Invokana® tablets.
Keywords: canagliflozin; degradation; drug analysis; greenness profile; stability.
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