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    
Abstract/OtherAbstract:
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).
Authors:
Anna Berecka; Anna Gumieniczek; Hanna Hopkała
Related Documents :
23307079 - Determination of 5-ethylidene-2-norbornene in industrial emission.
23605149 - Analysis of fusarium toxins via hplc-ms/ms multimethods: matrix effects and strategies ...
24098979 - On-line mass spectrometric methods for the determination of the primary products of fas...
24310099 - Quantitative and pattern recognition analyses of magnoflorine, spinosin, 6'''-feruloyl ...
23836529 - Hplc fluorescence method for the determination of nizatidine in human plasma and its ap...
23476029 - Rapid liquid chromatographic determination of itraconazole and its production impurities.
8287049 - New lectins from bulbs of croccus sativum.
22352409 - Simultaneous determination of glucoraphanin and sulforaphane in brassica oleracea seeds...
11130199 - A validation study comparing accelerator ms and liquid scintillation counting for analy...
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    
Affiliation:
Medical University of Lublin, Faculty of Pharmacy, Department of Medicinal Chemistry, Jaczewskiego Str. 4, 20-090 Lublin, Poland.
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:
Calibration
Carbamates / analysis*
Chemistry, Pharmaceutical
Chromatography, High Pressure Liquid
Gliclazide / analysis*
Hypoglycemic Agents / analysis*
Indicators and Reagents
Piperidines / analysis*
Reference Standards
Reproducibility of Results
Tablets
Chemical
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


Previous Document:  Single-view-point omnidirectional catadioptric cone mirror imager.
Next Document:  Spectrophotometric analysis of selective serotonin reuptake inhibitors based on formation of charge-...