反相高效液相色谱法测定盐酸齐拉西酮及有关物质  

Determination of Ziprasidone Hydrochloride and Related Substances by Reversed-phase High Performance Liquid Chromatography

作　　者：李妮[1] 郁韵秋[1] 沈顺[1] 

机构地区：[1]复旦大学药学院,上海200032

出　　处：《分析化学》2004年第7期916-918,共3页Chinese Journal of Analytical Chemistry

摘　　要：建立了盐酸齐拉西酮及有关物质的反相高效液相色谱测定法。采用C18色谱柱 ,以甲醇 5 0mmol/L醋酸钠缓冲溶液梯度洗脱 ,使盐酸齐拉西酮及 8个中间体基线分离 ,采用二极管阵列检测器 ,检测波长 2 5 4nm。各杂质的最低检出限均可满足测定的要求。建立的方法操作简便 ,重现性好 ,结果准确。A reversed-phase high performance liquid chromatographic method for analyzing ziprasidone hydrochloride and its related substances was established. The base-line separation of ziprasidone hydrochloride and 8 related substances was accomplished on a Diamonsil(TM) C-18 (150 mm x 4.6 mm, 5 mum) column. Methanol was used as the mobile phase A, while acetate buffer at pH 6.0 was employed as mobile phase B. Gradient elution was adopted at the detection of 254 nm with a diode array detector. The limit of detection of each related substance can satisfy for quality control purpose. It is simple, reproducible and accurate.

关 键 词：盐酸齐拉西酮 反相高效液相色谱法 含量测定 梯度洗脱 非典型抗精神病药 

分 类 号：O657.7[理学—分析化学] TQ463[理学—化学]