Liquid chromatography-tandem mass spectrometry simultaneous determination of repaglinide and metformin in human plasma and its application to bioequivalence study / 药学学报
Acta Pharmaceutica Sinica
;
(12): 547-553, 2013.
Article
in English
| WPRIM
| ID: wpr-235629
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Piperidines
/
Blood
/
Carbamates
/
Pharmacokinetics
/
Therapeutic Equivalency
/
Administration, Oral
/
Chromatography, Liquid
/
Area Under Curve
/
Drug Stability
/
Tandem Mass Spectrometry
Type of study:
Practice guideline
/
Prognostic study
Limits:
Adolescent
/
Adult
/
Female
/
Humans
/
Male
Language:
English
Journal:
Acta Pharmaceutica Sinica
Year:
2013
Type:
Article
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