Development of an HPLC-MS/MS method to determine janagliflozin in human plasma and urine: application in clinical study.

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.