Liquid chromatography-tandem mass spectrometry simultaneous determination of repaglinide and metformin in human plasma and its application to bioequivalence study.
- Author:
Xiao-Rong LIANG
1
;
Xiao-Jian DAI
;
Yi-Fan ZHANG
;
Jue-Fang DING
;
Xiao-Yan CHEN
;
Da-Fang ZHONG
Author Information
1. Zhejiang University of Technology, Hangzhou 310014, China.
- Publication Type:Journal Article
- MeSH:
Administration, Oral;
Adolescent;
Adult;
Area Under Curve;
Carbamates;
administration & dosage;
blood;
pharmacokinetics;
Chromatography, Liquid;
Drug Stability;
Female;
Humans;
Hypoglycemic Agents;
administration & dosage;
blood;
pharmacokinetics;
Male;
Metformin;
administration & dosage;
blood;
pharmacokinetics;
Middle Aged;
Piperidines;
administration & dosage;
blood;
pharmacokinetics;
Tandem Mass Spectrometry;
Therapeutic Equivalency;
Young Adult
- From:
Acta Pharmaceutica Sinica
2013;48(4):547-553
- CountryChina
- Language:English
-
Abstract:
A simple, sensitive, selective, and reproducible liquid chromatography-tandem mass spectrometric method was developed for the simultaneous determination of repaglinide and metformin in human plasma using d5-repaglinide and d6-metformin as internal standards (ISs). After a simple protein precipitation using acetonitrile as the precipitation solvent, both analytes and ISs were separated on a Venusil ASB C 18 (150 mm x 4.6 mm, 5 microm) via gradient elution using acetonitrile--10 mmol x L(-1) ammonium acetate as the mobile phase. A chromatographic total run time of 7.5 min was achieved. Mass spectrometric detection was conducted with atmospheric pressure chemical ionization under positive-ion and multiple-reaction monitoring modes. The method was linear over the 0.2 to 60.0 ng x mL(-1) concentration range for repaglinide and over the 4 to 1 000 ng x mL(-1) range for metformin. For both analytes, the intra- and inter-accuracies and precisions were within the +/- 15% acceptable limit across all concentrations. The validated method was successfully applied to a clinical bioequivalence study.
