RP-HPLC法测定盐酸齐拉西酮的含量  

Determination of Ziprasidone Hydrochloride by RP-HPLC with UV Detection

作　　者：李妮[1] 沈顺[1] 仲艳[1] 王兆莹 郁韵秋[1] 

机构地区：[1]复旦大学药学院药物分析教研室,上海200032 [2]上海市医药学校,上海200135

出　　处：《复旦学报（医学版）》2004年第6期656-657,共2页Fudan University Journal of Medical Sciences

摘　　要：目的　建立RP HPLC法测定盐酸齐拉西酮的含量。方法　以C18柱 (4 .6mm× 15 0mm ,5 μm)为固定相 ,甲醇 -水 (5 0mmol/L醋酸钠 ,用冰醋酸调节 pH至 6 .0 ) (75 :2 5 ,V/V)为流动相 ,流速 1.2mL/min ,检测波长 2 5 4nm ,柱温 2 5℃。结果　盐酸齐拉西酮的最低定量限为 10 .10ng ,线性范围 1.0 10～ 10 10 μg/mL ,r=1.0 0 0 ,日内、日间精密度RSD均 <2 %。结论　本方法简便、灵敏、准确 。Purpose: To establish an RP-HPLC method for the determination of Ziprasidone hydrochloride. Methods: A C18 (4.6 mm x 150 mm, 5 μm) column was adopted as stationary phase, Methanol-50 mmol/L sodium acetate solution (adjustment of pH to 6.0 with acetic acid) (75:25, V/V) was used as mobile phase, the flow rate was 1.2 mL/min, the detection wavelength was 254 nm, and the temperature of column was 25°C. Results: The limit of detection for Ziprasidone hydrochloride was 10.10 ng, the linearity was good at the range of 1.010-1010 μg/mL, R = 1.000. The intra-day and inter-day RSD of ziprasidone hydrochloride were both lower than 2%. Conclusions: The established method was simple, sensitive and accurate,and can be used for the determination and quality control of ziprasidone hydrochloride.

关 键 词：RP-HPLC法 齐拉西酮 含量测定 RSD 检测波长 灵敏 调节 盐酸 甲醇 醋酸钠 

分 类 号：R971.41[医药卫生—药品] TQ463.24[医药卫生—药学]