HPLC法同时测定夏天无配方颗粒4种成分含量  

Simultaneous Determination of Four Constituents in Corydalis Formula Granules by HPLC

作　　者：廖惠平 谢勇辉 曾慧芬 万文琴 朱小芳 眭荣春 LIAO Huiping;XIE Yonghui;ZENG Huifen;WAN Wenqin;ZHU Xiaofang;SUI Rongchun(Ji'an Central People's Hospital,Ji'an Jiangxi 343000,China;Jiangxi Universe Pharmaceutical Co.,LTD,Ji'an Jiangxi 343000,China)

机构地区：[1]吉安市中心人民医院,江西吉安343000 [2]江西大自然制药有限公司,江西吉安343000

出　　处：《药品评价》2024年第10期1187-1190,共4页Drug Evaluation

基　　金：2023年度吉安市指导性科技计划项目(20233-043703)。

摘　　要：目的 建立HPLC法同时测定夏天无配方颗粒中原阿片碱、盐酸巴马汀、比枯枯灵和延胡索乙素4种成分含量的方法。方法 采用Ultimate Plus C18色谱柱(250 mm×4.6 mm,5μm),以乙腈-0.1%磷酸溶液(用三乙胺调pH值至6.0)为流动相,梯度洗脱,流速为1.0 mL/min,柱温为35℃,检测波长为280 nm,进样量为10μL。结果 夏天无配方颗粒中原阿片碱、盐酸巴马汀、比枯枯灵和延胡索乙素分别在浓度为0.010 34~0.206 8 mg/mL(r=1.000 0)、0.005 45~0.109 0 mg/mL(r=1.000 0)、0.010 84~0.216 7 mg/mL(r=1.000 0)、0.021 17~0.423 4 mg/mL(r=1.000 0)范围内线性关系良好,重复性、稳定性和精密度均符合要求;平均加样回收率分别为99.57%、99.23%、100.18%、99.87%,RSD分别为0.66%、1.59%、1.54%、1.39%。结论 建立的HPLC分析方法简便、准确,可为夏天无配方颗粒的多指标成分质量控制提供参考。Objective To establish an HPLC method for the simultaneous determination of the contents of four constituents in corydalis formula granules:protopine,palmatine hydrochloride,bikukuling,and berberine.Methods The chromatographic determination was performed on Ultimate Plus C18 column(250 mm×4.6 mm,5μm)with acetonitrile-0.1%phosphoric acid solution(pH adjusted to 6.0 with triethylamine)as the mobile phase.Gradient elution was performed at the flow rate of 1.0 mL/min.The column temperature was 35℃,and the detection wavelength was 280 nm.The injection volume was 10μL.Results The concentrations of protopine,palmatine hydrochloride,bikukuling,and berberine were 0.01034-0.2068 mg/mL(r=1.0000),0.00545-0.1090 mg/mL(r=1.0000),0.01084-0.2167 mg/mL(r=1.0000)and 0.02117-0.4234 mg/mL(r=1.0000)in corydalis formula granules,respectively,the linear relationship was good,and the repeatability,stability and precision met the requirements.The average recoveries were 99.57%,99.23%,100.18%,99.87%,and RSDs were 0.66%,1.59%,1.54%,1.39%,respectively.Conclusion The method of HPLC is simple and accuratere,which can provide a method reference for the quality control of corydalis formula granules.

关 键 词：夏天无 配方颗粒 HPLC 含量测定 

分 类 号：O657.72[理学—分析化学] R286.0[理学—化学]