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

被引：7
|
作者：
Song, Ling [1 ,2 ,3 ]
Liu, Yang [1 ,2 ]
Yao, Xueting [1 ,2 ]
Liu, Hongzhong [1 ,2 ]
Chen, Bo [1 ,2 ]
Ma, Xifeng [4 ]
Zhou, Huimin [4 ]
Shih, Chengkon [4 ]
Jiang, Ji [1 ,2 ]
Chen, Xijing [3 ]
Hu, Pei [1 ,2 ]
Liu, Dongyang [1 ,2 ]
机构：
[1] Beijing Union Med Coll Hosp, Clin Pharmacol Res Ctr, Beijing, Peoples R China
[2] Chinese Acad Med Sci, Beijing, Peoples R China
[3] China Pharmaceut Univ, Sch Basic Med & Clin Pharm, Clin Pharmacokinet Lab, Nanjing, Jiangsu, Peoples R China
[4] XuanZhu Pharma Co Ltd, Jinan 250101, Shandong, Peoples R China
来源：
BIOANALYSIS | 2018年 / 10卷 / 17期
基金：
中国国家自然科学基金;
关键词：
human plasma and urine; janagliflozin; LC-MS/MS; TANDEM MASS-SPECTROMETRY; 2; SGLT-2; INHIBITOR; RAT PLASMA; ADDUCT-IONS; CANAGLIFLOZIN; DAPAGLIFLOZIN; UPDATE;
D O I：
10.4155/bio-2018-0129
中图分类号：
Q5 [生物化学];
学科分类号：
071010 ; 081704 ;
摘要：
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.
引用
收藏
页码：1439 / 1454
页数：16
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