Document Detail

Development and validation of a new high-performance liquid chromatography method for the determination of gliclazide and repaglinide in pharmaceutical formulations.
MedLine Citation:
PMID:  16640279     Owner:  NLM     Status:  MEDLINE    
A new high-performance liquid chromatography method was developed and validated for the quantitation of gliclazide and repaglinide in pharmaceutical formulations. Determination was performed using a LiChroCART RP-18 column, a mobile phase containing acetonitrile-phosphate buffer (pH 2.1; 60 + 40, v/v), and ultraviolet (UV) detection at 225 nm. Repaglinide was used as an internal standard for gliclazide determination and gliclazide for repaglinide assay. The method was validated with respect to linearity, precision, robustness, ruggedness, accuracy, and specificity. The calibration graphs ranged from 0.015 to 0.09 mg/mL for gliclazide and 0.06 to 0.36 mg/mL for repaglinide. Intra- and interday relative standard deviation values for the standard solutions were 0.70 and 1.01% for gliclazide and 0.78 and 0.93% for repaglinide, respectively. Total recoveries of gliclazide and repaglinide from the laboratory-prepared mixtures were 99.82 +/- 0.58 and 101.50 +/- 0.46% for gliclazide and repaglinide, respectively [mean +/- standard deviation (SD)]. In forced degradation studies, the effect of acid, base, oxidation, UV light, and temperature on both drugs was also investigated. Finally, the method was applied for the quality control of commercial gliclazide and repaglinide tablets. Total recovery was 100.40 +/- 0.35 and 104.46 +/- 0.23% for gliclazide and repaglinide, respectively (mean +/- SD).
Anna Berecka; Anna Gumieniczek; Hanna Hopkała
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of AOAC International     Volume:  89     ISSN:  1060-3271     ISO Abbreviation:  J AOAC Int     Publication Date:    2006 Mar-Apr
Date Detail:
Created Date:  2006-04-27     Completed Date:  2006-05-23     Revised Date:  2008-03-17    
Medline Journal Info:
Nlm Unique ID:  9215446     Medline TA:  J AOAC Int     Country:  United States    
Other Details:
Languages:  eng     Pagination:  319-25     Citation Subset:  IM    
Medical University of Lublin, Faculty of Pharmacy, Department of Medicinal Chemistry, Jaczewskiego Str. 4, 20-090 Lublin, Poland.
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MeSH Terms
Carbamates / analysis*
Chemistry, Pharmaceutical
Chromatography, High Pressure Liquid
Gliclazide / analysis*
Hypoglycemic Agents / analysis*
Indicators and Reagents
Piperidines / analysis*
Reference Standards
Reproducibility of Results
Reg. No./Substance:
0/Carbamates; 0/Hypoglycemic Agents; 0/Indicators and Reagents; 0/Piperidines; 0/Tablets; 135062-02-1/repaglinide; 21187-98-4/Gliclazide

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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