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Determination of gliclazide in serum by high-performance liquid chromatography using solid-phase extraction
H Noguchi1, N Tomita, S Naruto
1Exploratory Research Laboratories, Dainippon Pharmaceutical Co., Ltd., Osaka, Japan.
Journal of Chromatography
|December 2, 1992
Summary
A new high-performance liquid chromatography method accurately measures gliclazide in serum. This sensitive assay, using glibenclamide as an internal standard, achieves a minimum detectable level of 20 ng/ml for routine clinical analysis.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Background:
- Gliclazide is a widely used oral hypoglycemic agent for type 2 diabetes.
- Accurate quantification of gliclazide in biological matrices is crucial for therapeutic drug monitoring and pharmacokinetic studies.
Purpose of the Study:
- To develop and validate a simple, sensitive, and reliable high-performance liquid chromatographic (HPLC) method for the routine determination of gliclazide in human serum.
Main Methods:
- Serum samples were processed using Bond Elut C18 cartridges for solid-phase extraction.
- Gliclazide was separated on an octadecyl silica column using a mobile phase of potassium dihydrogenphosphate, acetonitrile, and isopropyl alcohol.
- Quantification was achieved using ultraviolet detection at 227 nm with glibenclamide as the internal standard.
Main Results:
- The developed HPLC method demonstrated high sensitivity with a minimum detectable level of 20 ng/ml for gliclazide.
- The method provided a robust and reproducible assay for serum gliclazide quantification.
Conclusions:
- The established HPLC method is suitable for the routine, sensitive, and accurate assay of gliclazide in serum samples.
- This method facilitates effective therapeutic drug monitoring for patients on gliclazide treatment.