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Development of an HPLC-MS/MS method to determine janagliflozin in human plasma and urine: application in clinical
Ling Song1,2, Yang Liu1, Xueting Yao1
1Clinical Pharmacology Research Center, Peking Union Medical College Hospital & Chinese Academy of Medical Sciences, Beijing, PR China.
Aim:
Janagliflozin is a novel, orally selective sodium-glucose co-transporter-2 (SGLT2) inhibitor, which showed good efficacy and safety in preclinical study. The objective of this study is to develop and validate the HPLC-MS/MS method to determine janagliflozin in both of human urine and plasma.
Methods:
Janagliflozin was separated on Waters Xbridge Phenyl C18 column and detected on API 4000 tandem mass spectrometer with ESI source in negative mode.
Results:
This method provided good linearity in the range of 5-5000 ng/ml and 5-1000 ng/ml in plasma and urine. The matrix effect and extraction recoveries across three concentration levels were consistent.
Conclusion:
This validated method is reliable and has been successfully applied to a first-in-human trial of janagliflozin in Chinese subjects.
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