Validation of analytical method for the determination of glimepiride in human plasma by HPLC/UV with addition standard using glibenclamide as an internal standard
Keywords:
Glimepiride, Glibenclamide, Liquid-liquid extraction, addition standard method, HPLC/UVAbstract
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.Downloads
References
Hoeschst-Roussel Pharmaceuticals. Prescribing Information. Division of Aventis Pharmaceuticals In Kansas. July 2001.
www.aventispharma-us.com. Monograph Amaryl tablets (Glimepiride). 2001.
RxList – Glimepiride. http://www.rxlist.com
Meinert C L., et al. A Study of the effects of Hipoglycemic Agents on Vascular Complications in Patients with Adult onset Diabetes II. Mortality Results. Diabetes. 1970
Niopas, Ioannis and Athanasios C. Daftsios. A Validated high-performance liquid chromatographic method for the determination of glibenclamide in human plasma and its application to pharmacokinetic studies. Journal of Pharmaceutical and Biomedical analysis. Vol. 28, issues 3-4. May. 2002.
Institute of Biomedical Sciences – USP. The Determination of Glimepiride in Human Plasma by LC-MS/MS using Glibenclamide as the Internal Standard. SOP No. 05/01.. Brazil.
Valdéz, J. González E. Determination of Glibenclamide in Human Plasma by solid - phase extraction and High - Performance Liquid chromatography. J. Chromatogr., B: Biome. Appl. 12 jul. 1996. 682 (2), 364-370.
Hohyun, Kim, et al. Determination of Glimepiride in Human Plasma by Liquid Chromatography-Electrospray Ionization Tandem Mass Spectrometry. Bull. Korean Chem. Soc. 2004. Vol. 25, No. 1.
FDA. Guidance for the Industry. Bioanalytical Method Validation. May 2001.
Ibid viii.
FDA. Guidance for the Industry. Analytical Method Validation. Aug 2000.
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