磷酸苯丙哌林原料药有关物质检测新方法

A New Method for Determination of Related Substances in Benproperine Phosphate Bulk Drug

目的:磷酸苯丙哌林现行质量标准(《中国药典》2015版)只规定了总杂限度,且无法有效的分离所有杂质,不能完全控制其有关物质。本研究优化了HPLC方法,以便完善有关物质的检查。方法:对HPLC梯度洗脱法进行方法学考察,并用此法将原料药中的杂质进行分离纯化。结果:建立了磷酸苯丙哌林梯度洗脱的液相色谱方法,经梯度洗脱检测出两个杂质。结论:新建立的有关物质梯度洗脱HPLC法专属性强,结果准确,耐用性良好,可有效控制磷酸苯丙哌林中的有关物质。

Objective: Benproperine phosphate is an antitussive drug founded by Swedish scientists,which is stronger than codeine and treatable for all kinds of coughs.Current quality standards cannot completely control the related substances.In the 2015 edition of Chinese pharmacopoeia,HPLC is used for the detection of related substances,but all impurities could not be separated effectively,and only the total impurities can be limited.The objective of this project is to optimize HPLC for gradient elution and improve the inspection of related substances.Methods: The gradient elution of HPLC was used to separate and purify the impurities in the API.Results: A gradient elution method for phenylpropylline phosphate by liquid chromatography was established.Two impurities were detected by gradient elution.Conclusion: The gradient elution of HPLC for benproperine phosphate has strong specificity,accurate results and good durability,which can be used for quality control of benproperine phosphate related substances.