HPLC 测定感冒退热颗粒中 (R,S)- 告依春含量.PDF

HPLC 测定感冒退热颗粒中(R,S)-告依春含量 邹耀华，刘宇文(杭州市药品检验所，杭州 310017) 摘要：目的 建立 HPLC 快速测定感冒退热颗粒中(R,S)-告依春含量的方法，以控制其质量。方法 色谱柱：Inertsil ODS-SP(4.6 mm×250 mm ，5 μm) ；流动相：乙腈-0.08%磷酸溶液(含 0.04%三乙胺)(5 ∶95) ；流速：1.0 mL ·min?1；检测 波长：245 nm ；柱温：30℃。结果 (R,S)-告依春在 0.010 44～0.522 μg 内线性良好(r ＝0.999 9)，加样回收率为 99.7% ， RSD 为 0.79%(n =9)，不同厂家生产的感冒退热颗粒中(R,S)-告依春含量差异较大。结论 本实验所建立的方法简单、准 确、快速，可为制药企业或药品监督管理部门控制感冒退热颗粒的质量提供一定的参考。 关键词：高效液相色谱法；感冒退热颗粒；(R,S)-告依春 中图分类号：R927.2; R917.101 文献标志码：A 文章编号：1007-7693(2011)11-1035-03 Determination of Epigoitrin Content in Ganmao Tuire Granules by HPLC ZOU Yaohua, LIU Yuwen(Hangzhou Institute for Drug Control, Hangzhou 310017, China) ABSTRACT: OBJECTIVE To establish a method for rapid determination of epigoitrin content in Ganmao Tuire Granules. METHODS The sample was extracted by water and separated by Inertsil ODS-SP column, the mobile phase was acetonitrile-triethylamine phosphoric acid solution (included 0.08% phosphoric acid and 0.04% triethylamine) (5 ∶95), the detection wavelength was at 245 nm , flow rate was 1.0 mL·min?1, the column temperature was at 30 ℃. RESULTS The linear range of epigoitrin was in 0.010 44?0.522 μg(r =0.999 9) . The average recovery was 99.7% with RSD of 0.79% (n =9). The epigoitrin content in Ganmao Tuire Granules was obviously different from different pharmaceutical factories. CONCLUSION This method is simple, rapid and reproducible, and it can be used as a low-cost, convenient method for measuring epigoitrin content in Ganmao Tuire Granules, and it can provide reference for relative company and state food and drug administration. KEY WORDS: HPLC; ganmao tuire granules; epigoitrin 感冒退热颗粒收载于中国药典 2010 年版一 其质量标准提供科学依据。 部，由大青叶、板蓝根、连翘及拳参四味中药组 1 仪器与试剂 成[1]，具有清热解毒、疏风解表之功效，临床上主