Development of an HPLC–MS/MS method to determine janagliflozin in human plasma and urine: application in clinical study
- Resource Type
- Authors
- Yang Liu; Bo Chen; Ji Jiang; Pei Hu; Xueting Yao; Hongzhong Liu; Xifeng Ma; Dongyang Liu; Chengkon Shih; Huimin Zhou; Ling Song; Xijing Chen
- Source
- Bioanalysis. 10:1439-1454
- Subject
- Clinical Biochemistry
Urine
Urinalysis
030226 pharmacology & pharmacy
01 natural sciences
Analytical Chemistry
Clinical study
03 medical and health sciences
0302 clinical medicine
Tandem Mass Spectrometry
Lc ms ms
Humans
Medicine
Canagliflozin
General Pharmacology, Toxicology and Pharmaceutics
Chromatography, High Pressure Liquid
Chromatography
business.industry
010401 analytical chemistry
General Medicine
Healthy Volunteers
0104 chemical sciences
Medical Laboratory Technology
Hplc ms ms
Human plasma
Linear Models
business
Blood Chemical Analysis
- Language
- ISSN
- 1757-6199
1757-6180
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.