Structural studies on the impurities of troglitazone |
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Authors: | Moses Babu J Nageshwar D Ravindra Kumar Y Prabhakar C Sarma M R Om Reddy G Vyas K |
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Affiliation: | Department of Analytical Research, Discovery Research Division, Dr. Reddy's Laboratories Ltd., Bollaram Road, Miyapur, Hyderabad 500050, India. |
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Abstract: | 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. |
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