A concise review of the bioanalytical methods for the quantitation of sitagliptin, an important dipeptidyl peptidase-4 (DPP4) inhibitor, utilized for the characterization of the drug

被引:14
作者
Suresh, P. S. [1 ]
Srinivas, Nuggehally R. [2 ]
Mullangi, Ramesh [1 ]
机构
[1] Jubilant Biosys, 2nd Stage,Ind Suburb, Bangalore 560022, Karnataka, India
[2] Suramus Bio Drug Dev, Bangalore 560078, Karnataka, India
关键词
sitagliptin; HPLC; LC-MS/MS; bioanalytical methods; review; MASS-SPECTROMETRY METHOD; HUMAN PLASMA; LIQUID-CHROMATOGRAPHY; CHIRAL INVERSION; LC-MS/MS; ONLINE EXTRACTION; DOUBLE-BLIND; METFORMIN; VALIDATION; PHARMACOKINETICS;
D O I
10.1002/bmc.3705
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
Inhibition of dipeptidyl peptidase-4 (DPP4) is an emerging therapeutic approach for treating type 2 diabetes and has revolutionized the concept of diabetes management. Sitagliptin is the first approved orally active, potent, selective and nonpeptidomimetic DPP4 inhibitor. Incidence of hypoglycemia and weight gain is negligible with sitagliptin treatment. It is used as monotherapy or in combination with other anti-diabetic drugs to treat type 2 diabetes. There are numerous bioanalytical methods published for the analysis of sitagliptin in preclinical and clinical samples. This review focuses on the various HPLC and LC-MS/MS methods that have been used to analyze sitagliptin in various biological matrices. A small section is devoted to the bioanalysis of other DPP4 inhibitors such as vildagliptin, saxagliptin and linagliptin. This review provides key information in a concise manner regarding sample processing options, chromatographic/detection conditions and validation parameters of the chosen methods for sitagliptin and other DPP4 inhibitors. Copyright (C) 2016 John Wiley & Sons, Ltd.
引用
收藏
页码:749 / 771
页数:23
相关论文
共 47 条
[41]   Metabolism and excretion of the dipeptidyl peptidase 4 inhibitor [14C]sitagliptin in humans [J].
Vincent, Stella H. ;
Reed, James R. ;
Bergman, Arthur J. ;
Elmore, Charles S. ;
Zhu, Bing ;
Xu, Shiyao ;
Ebel, David ;
Larson, Patrick ;
Zeng, Wei ;
Chen, Li ;
Dilzer, Stacy ;
Lasseter, Kenneth ;
Gottesdiener, Keith ;
Wagner, John A. ;
Herman, Gary A. .
DRUG METABOLISM AND DISPOSITION, 2007, 35 (04) :533-538
[42]   Liquid chromatography and tandem mass spectrometry method for the quantitative determination of saxagliptin and its major pharmacologically active 5-monohydroxy metabolite in human plasma: Method validation and overcoming specific and non-specific binding at low concentrations [J].
Xu, Xiaohui ;
Demers, Roger ;
Gu, Huidong ;
Christopher, Lisa J. ;
Su, Hong ;
Cojocaru, Laura ;
Boulton, David W. ;
Kirby, Mark ;
Stouffer, Bruce ;
Humphreys, William G. ;
Arnold, Mark E. .
JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES, 2012, 889 :77-86
[43]  
Yao T, 2011, CHINESE J CHROMATOGR, V29, P475
[44]   Determination of MK-0431 in human plasma using high turbulence liquid chromatography online extraction and tandem mass spectrometry [J].
Zeng, W ;
Musson, DG ;
Fisher, AL ;
Wang, AQ .
RAPID COMMUNICATIONS IN MASS SPECTROMETRY, 2006, 20 (08) :1169-1175
[45]   Determination of sitagliptin in human urine and hemodialysate using turbulent flow online extraction and tandem mass spectrometry [J].
Zeng, Wei ;
Musson, Donald G. ;
Fisher, Alison L. ;
Chen, Li ;
Schwartz, Michael S. ;
Woolf, Eric J. ;
Wang, Amy Qiu .
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2008, 46 (03) :534-542
[46]   Determination of sitagliptinin human plasma using protein precipitation and tandem mass spectrometry [J].
Zeng, Wei ;
Xu, Yang ;
Constanzer, Marvin ;
Woolf, Eric J. .
JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES, 2010, 878 (21) :1817-1823
[47]   Sitagliptin phosphate: A DPP-4 inhibitor for the treatment of type 2 diabetes mellitus [J].
Zerilli, Tina ;
Pyon, Eunice Y. .
CLINICAL THERAPEUTICS, 2007, 29 (12) :2614-2634