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目的建立高效液相色谱法测定盐酸双苯氟嗪原料药和注射用粉针剂的含量及其有关物质的方法。方法采用Restek C_(18)色谱柱,流动相为缓冲溶液-乙腈-甲醇(43:10:47,用磷酸调节pH值至3.5),流速为1mL/min,检测波长为230nm,柱温为35℃。结果盐酸双苯氟嗪在19.74～592.2mg/L范阿内线性关系良好,r~2=1.000 0,平均回收率为99.4%,相对标准差为1.0%。结论本方法准确、简便、灵敏,可用于盐酸双苯氟嗪及其制剂的含量测定和有关物质检查。
Objective To establish a HPLC method for the determination of dipfluzine hydrochloride and injection powder and its related substances. Methods Restek C_ (18) column was used. The mobile phase was buffer - acetonitrile - methanol (43:10:47, adjusted to pH 3.5 with phosphoric acid), the flow rate was 1 mL / min, the detection wavelength was 230 nm and the column temperature was 35 ℃. Results Dipfluzine hydrochloride showed good linearity in the range of 19.74-592.2 mg / L. The average recovery was 99.4% and the relative standard deviation was 1.0%. Conclusion The method is accurate, simple and sensitive and can be used for the determination of dipfluzine hydrochloride and its preparations and related substances.