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目的:建立一种测定元胡止痛口服液中延胡索乙素含量的高效液相色谱方法。方法:收集10批元胡止痛片,经过全面、规范的方法学验证,确定色谱条件为:C18柱(4.6mm×250mm,5μm);流动相为乙腈-0.1%磷酸溶液(三乙胺调pH6.0)(40∶60);检测波长280nm。结果:延胡索乙素在5.09～71.23μg·mL-1时,质量浓度与峰面积积分值呈良好的线性关系,r=0.99997,平均回收率101.28%,RSD2.05%;含量限度定为每1mL含延胡索乙素不得少于80μg。结论:该方法简便、快速、准确,可用于元胡止痛口服液中延胡索乙素的含量控制。
Objective: To establish a HPLC method for the determination of tetrahydropalmatine in Yuanhu Zhitong Oral Liquid. METHODS: Ten batches of Yuanhu painkiller tablets were collected and verified by a comprehensive and standardized method. The chromatographic conditions were as follows: C18 column (4.6mm × 250mm, 5μm); acetonitrile-0.1% phosphoric acid solution .0) (40:60); detection wavelength 280nm. Results: The calibration curve was linear at a concentration of 5.09 ~ 71.23μg · mL-1, r = 0.99997, with an average recovery of 101.28% and a RSD of 0.05%, and the limit of quantification was 1mL Tetrahydropalmatine should not be less than 80μg. Conclusion: The method is simple, rapid and accurate and can be used for the content control of tetrahydropalmatine in Yuanhu Zhitong Oral Liquid.