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

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.