摘要
Ahn To establish an RP-HPLC method for determination of content of 1-phenylpropanol in its raw material and preparations. Methods Chromatography was carried out on a Dikma DiamonsilTM ODS column, using a mobile phase of methanol-water （55：45） with a flow rate at 1.0 mL·min^-1. The detection wavelength was 258 nm. Results Under the chromatographic condition, the peaks of 1-phenylpropanol and its related impurities separated completely; noninterference between the principal agent and adjuvants in preparations was performed. The calibration curve was linear over the range of 250 - 750μg·mL^-1 with the correlation coefficient of 0. 999 9. The average recovery was 100.2% （ RSD = 1.35% ）. Conclusion This method is simple, rapid, accurate, specific, and can be used to detect the content and related compounds of phenylpropanol in its raw material and preparations.
目的 建立苯丙醇原料药及其制剂中药物含量测定和有关杂质检查的反相高效液相色谱（RP-HPLC）。方法 采用迪马Diamonsil^TM ODS（200mm×4．6mm，5μm），流动相为：甲醇-水（55：45），检测波长为258nm，流速为1.0mL·min^-1。结果 在选定的色谱条件下，苯丙醇与有关杂质完全分离，制剂中辅料对主药无干扰；在250-7500644g·mL^-1范围内，峰面积与浓度线性关系良好，相关系数r=0．9999；平均回收率为100．2％，RSD=1．35％。结论 本法简单、快速、准确、专属性强，可作为苯丙醇原料及其制剂含量测定和有关物质检查方法。
