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目的建立简便、灵敏的手性高效液相色谱法检查苄基依折麦布中的异构体杂质。方法以Chiralpak IC为固定相,正己烷-异丙醇(体积比90∶10)为流动相,流速为1.0 m L·min-1,检测波长为232 nm。结果通过对分离条件进行优化,苄基依折麦布与其异构体杂质能达到良好分离。苄基依折麦布在质量浓度为1.0~12 mg·L-1内线性关系良好。平均回收率为99.8%,日内与日间精密度均小于3.0%。结论所建立的分析方法灵敏度高、重现性好,适用于苄基依折麦布中异构体杂质的检查。
Objective To establish a simple and sensitive chiral HPLC method for the determination of isomer impurities in benzyl ezetimibe. Methods Chiralpak IC was used as stationary phase, n - hexane - isopropanol (90:10 by volume) as the mobile phase at a flow rate of 1.0 m L · min-1 and a detection wavelength of 232 nm. Results By optimizing the separation conditions, benzyl ezetimibe and its isomer impurities can be well separated. Benzyl ezetimibe showed good linearity in the range of 1.0-12 mg · L-1. The average recovery rate was 99.8%. The intra- and inter-day precision was less than 3.0%. Conclusion The analytical method established has high sensitivity and good reproducibility and is suitable for the examination of isomer impurities in benzyl ezetimibe.