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-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.
Moses Babu
J
J
Department of Analytical Research, Discovery Research Division, Dr. Reddy's Laboratories Ltd., Bollaram Road, Miyapur, Hyderabad 500050, India.
Nageshwar
D
D
Ravindra Kumar
Y
Y
Prabhakar
C
C
Sarma
M R
MR
Om Reddy
G
G
Vyas
K
K
D002839:Chromans / Q000737:chemistry / Q000302:isolation & purification*; D002851:Chromatography, High Pressure Liquid; D007004:Hypoglycemic Agents / Q000737:chemistry / Q000302:isolation & purification*; D009682:Magnetic Resonance Spectroscopy; D013058:Mass Spectrometry; D015394:Molecular Structure; D013844:Thiazoles / Q000737:chemistry / Q000302:isolation & purification*; D045162:Thiazolidinediones; D000077288:Troglitazone; D014961:X-Ray Diffraction
D002839:Chromans; D007004:Hypoglycemic Agents; D013844:Thiazoles; D045162:Thiazolidinediones; D000077288:Troglitazone