Structural studies on the impurities of troglitazone

The impurity profile study of troglitazone has been carried out primarily by (liquid chromatography–mass spectrometry) LC–MS. Four process-related impurities have been detected by LC–MS and were confirmed by co-injection with authentic samples. Apart from the process-related impurities, two polar by...

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Bibliographic Details
Published in:Journal of pharmaceutical and biomedical analysis 2003-02, Vol.31 (2), p.271-281
Main Authors: Moses Babu, J, Nageshwar, D, Ravindra Kumar, Y, Prabhakar, C, Sarma, M.R, Om Reddy, G, Vyas, K
Format: Article
Language:English
Subjects:
Analysis
Biological and medical sciences
Chromans - chemistry
Chromans - isolation & purification
Chromatography, High Pressure Liquid
General pharmacology
Hypoglycemic Agents - chemistry
Hypoglycemic Agents - isolation & purification
Identification and characterization
Impurities
LC–MS
Magnetic Resonance Spectroscopy
Mass Spectrometry
Medical sciences
Molecular Structure
NMR
Pharmacology. Drug treatments
Thiazoles - chemistry
Thiazoles - isolation & purification
Thiazolidinediones
Troglitazone
X-Ray Diffraction
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Summary:The impurity profile study of troglitazone has been carried out primarily by (liquid chromatography–mass spectrometry) LC–MS. Four process-related impurities have been detected by LC–MS and were confirmed by co-injection with authentic samples. Apart from the process-related impurities, two polar by-products were characterized by mass spectral data and comparison with reference samples, while one non-polar by-product and one degradation product have been isolated by means of preparative HPLC and characterized by 2D NMR and mass spectral study. Single-crystal X-ray diffraction studies have been carried out on the degradation product. The formation and characterization of these by-products and degradation product are discussed.
ISSN:0731-7085
1873-264X
DOI:10.1016/S0731-7085(02)00665-9