作者: Nobuyuki Suzuki , Akira Takemura , Akifumi Miyamoto , Takao Yoshioka , Shinya Tsutsumi
DOI: 10.1016/S0731-7085(02)00391-6
关键词: Dosage form 、 Thiazolidine 、 Methanol 、 Repeatability 、 Response factor 、 Chromatography 、 Reversed-phase chromatography 、 High-performance liquid chromatography 、 Analytical chemistry 、 Troglitazone 、 Chemistry
摘要: Abstract A simple HPLC method for the direct chiral separation of troglitazone stereoisomers was developed. The performed on a reversed-phase cellulose-derivertized column (Chiralcel OJ-R) using mobile phase consisting methanol–acetic acid (1000:1, v/v) at flow rate 0.5 ml/min. peak areas separated from 0.13 to 0.75 mg/ml had good linearity, with correlation coefficients >0.999 in mode. repeatability ratios isolated relative standard deviation 0.1–0.2%. sensitivities four isomers UV 285 nm were similar, as each response factor within range 0.99–1.01. Troglitazone racemized center thiazolidine ring methanol solution, but found be stable 24 h v/v). This applied stereoisomeric analysis pharmaceutical formulations and used evaluate constancy stereoisomer ratio manufacturing process stability testing.