LC determination of glimepiride and its related impurities

Five impurities in glimepiride drug substance were detected and quantified using a simple isocratic reverse phase HPLC method. For the identification and characterization purpose these impurities were isolated from a crude reaction mixture of glimepiride using a normal phase HPLC system. Based on th...

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Bibliographic Details
Published in:Journal of pharmaceutical and biomedical analysis 2005-10, Vol.39 (5), p.928-943
Main Authors: Khan, Mubeen Ahmad, Sinha, Sukumar, Vartak, Santosh, Bhartiya, Atul, Kumar, Shankar
Format: Article
Language:English
Subjects:
Analysis
Analytical, structural and metabolic biochemistry
API
Biological and medical sciences
Characterization
Chromatography, High Pressure Liquid
Drug Contamination
Drug Stability
Fundamental and applied biological sciences. Psychology
General pharmacology
Glimepiride
HPLC
Hypoglycemic Agents - analysis
Indicators and Reagents
Isomerism
Magnetic Resonance Spectroscopy
Medical sciences
Pharmacology. Drug treatments
Reference Standards
Related impurities
Reproducibility of Results
Solutions
Spectrometry, Mass, Electrospray Ionization
Spectrophotometry, Ultraviolet
Spectroscopy, Fourier Transform Infrared
Sulfonylurea Compounds - analysis
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Summary:Five impurities in glimepiride drug substance were detected and quantified using a simple isocratic reverse phase HPLC method. For the identification and characterization purpose these impurities were isolated from a crude reaction mixture of glimepiride using a normal phase HPLC system. Based on the spectroscopic data like NMR, FTIR, UV and MS these impurities were characterized and used as impurity standards for determining the relative response factor during the validation of the proposed isocratic reverse phase HPLC method. The chromatographic separation was achieved on a Phenomenex Luna C8 (2) 100 Å, 5 μm, 250 mm × 4.6 mm using a mobile phase consisting of phosphate buffer (pH 7.0)–acetonitrile–tetrahydrofuran (73:18:09, v/v/v) with UV detection at 228 nm and a flow rate of 1 ml/min. The column temperature was maintained at 35 °C through out the analysis. The method has been validated as per international guidelines on method validation and can be used for the routine quality control analysis of glimepiride as active pharmaceutical ingredient (API).
ISSN:0731-7085
1873-264X
DOI:10.1016/j.jpba.2005.06.007