RP-HPLC法测定盐酸齐拉西酮的含量

Determination of Ziprasidone Hydrochloride by RP-HPLC with UV Detection

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.