高效液相色谱法测定元胡止痛口服液中延胡索乙素的含量

Determination of Tetrahydropalmatine in Yuanhuzhitong Oral Liquor by HPLC

摘要:

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(4.6 mm×250 mm,5 μm);流动相为乙腈-0.1％磷酸溶液(三乙胺调pH 6.0)(40 ∶60);检测波长280 nm。 结果: 延胡索乙素在5.09~71.23 μg ·mL^-1时,质量浓度与峰面积积分值呈良好的线性关系,r＝0.999 97,平均回收率101.28％,RSD2.05％;含量限度定为每1 mL含延胡索乙素不得少于80 μg。 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。

Abstract:

Objective: To establish a HPLC method for determination of tetrahydropalmatine in Yuanhuzhitong Oral Liquor. Method: 10 batches of Oral Liquor were collected. The HPLC determination method was established after comprehensive and standardized methodology validation: C₁₈ column(4.6 mm×250 mm, 5 μm) was used. The mobile phase was acetonitrile-0.1% phosphoric acid solution(adjusted to pH6.0 with triethylamine) (40 ∶60). The detecting wavelength was 280 nm. Result: The linear detection ranges of tetrahydropalmatine were 5.09~71.23 μg ·mL^-1 (r＝0.999 97), and the average recovery was 101.28％(RSD 2.05％); The content of tetrahydropalmatine shall not be less than 80 μg per mL. Conclusion: This method is convenient, rapid and accurate, which could be used for quality control in Yuanhuzhitong Oral Liquor.