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.
Artículo
en Inglés
| 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.
Texto completo:
Disponible
Índice:
WPRIM (Pacífico Occidental)
Asunto principal:
Piperidinas
/
Sangre
/
Carbamatos
/
Farmacocinética
/
Equivalencia Terapéutica
/
Administración Oral
/
Cromatografía Liquida
/
Área Bajo la Curva
/
Estabilidad de Medicamentos
/
Espectrometría de Masas en Tándem
Tipo de estudio:
Guía de Práctica Clínica
/
Estudio pronóstico
Límite:
Adolescente
/
Adulto
/
Femenino
/
Humanos
/
Masculino
Idioma:
Inglés
Revista:
Acta Pharmaceutica Sinica
Año:
2013
Tipo del documento:
Artículo
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