Validation of analytical method for the determination of glimepiride in human plasma by HPLC/UV with addition standard using glibenclamide as an internal standard

Authors

  • G MILENA Q.F. Director del Laboratorio Biofarmacéutico. CIDEIM
  • G RAMÍREZ Q.F. Asistente de Investigación. CIDEIM.
  • O VELÁSQUEZ Ph.D. Químico. Asesor validación de la metodología analítica. ECOQUÍMICA.
  • M PÉREZ Estadístico. Unidad de Biometría. CIDEIM.
  • P RESTREPO MSc. Farmacología. Coordinador Unidad de Estudios Biofarmacéuticos. CIDEIM.

Keywords:

Glimepiride, Glibenclamide, Liquid-liquid extraction, addition standard method, HPLC/UV

Abstract

A method for detection and quantification of Glimepiride in human plasma has been developed using anisocratic elution on reversed phase liquid chromatography with ultraviolet detection at a single wavelength(231 nm) and the addition standard method. Glibenclamide was used as an internal standard. This methodinvolves a liquid-liquid drug extraction (Glimepiride and Glibenclamide) from plasma using dichloromethanediethylether (30:70%v/v). Separation was achieved on a C18 reversed phase column and the mobile phaseconsisted of 45% acetonitrile and 55% water (adjusted to pH 3.3±0.1 with acetic acid glacial). The assayhas been validated over a concentration range of 0.001 to 1.0 μg/mL with addition of Glimepiride 0.25μg/mL. Calibration curve was linear in the described concentration range. The reproducibility, stabilityand recovery of the method were evaluated. Determination of Glimepiride in human plasma by HPLC/UV method was accurate and precise with a quantitation limit of 0.2025 μg/mL. The method wassufficiently sensitive for pharmacokinetic studies of Glimepiride in human plasma.

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References

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Published

2005-09-20

How to Cite

1.
MILENA G, RAMÍREZ G, VELÁSQUEZ O, PÉREZ M, RESTREPO P. Validation of analytical method for the determination of glimepiride in human plasma by HPLC/UV with addition standard using glibenclamide as an internal standard. Ars Pharm [Internet]. 2005 Sep. 20 [cited 2025 Jul. 28];46(4):411-27. Available from: https://revistaseug.ugr.es/index.php/ars/article/view/5096

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Original Articles