HPLC法测定氢溴酸高乌甲素注射液的含量  

Determination of lappaconite hydrobromide injection by high performance liquid chromatography

作　　者：陈露[1] 蔡姗英[1] 鲁秋红[1] 

机构地区：[1]海南省药品检验所,海南海口570216

出　　处：《中国热带医学》2013年第11期1312-1315,共4页China Tropical Medicine

摘　　要：目的建立氢溴酸高乌甲素注射液的HPLC含量测定方法。方法采用依利特Hypersil BDS C18(5μm,4.6×250mm)为分析柱,流动相为0.04mol·L-1磷酸二氢钾溶液:甲醇:乙腈(68:17:15),流速1.0mL·min-1,检测波长252nm。结果浓度在11.48～137.76μg·mL-1范围内与色谱峰面积呈线性关系(r=0.9999),平均加样回收率99.4%(n=9)。60批注射液采用HPLC法测定,含量明显低于UV法测定结果。结论该方法简便、快速,专属性强,精密度良好,为评价和控制氢溴酸高乌甲素注射液的质量提供了依据。Objective To develop a method for determination of lappaconite hydrobromide in its injection by high performance hquid chromatography （HPLC）. Methods The assay was performed on hypersil BDS C18 （5μm,4.6 × 250 mm） with mobile phase of 0.04 mol·L-1 KH2PO4：Methanol：Water （68：17：15） at the flow rate of 1.0 mL·min-1,and detective wavelength was 252 nm. Results The standard curve showed a good linear relationship between the concentration range of 11.48-137.76μg·mL-1 （r=0.9999） and the peak area. The average recovery was 99.4% （n=9）. The determination results of 60 batches of lappaeonite hydrobromide injection measured by HPLC were lower than that determined by UV. Conclusions The HPLC method is convenient,quickly,selectively and accurate,which may provide the basis for the quality evaluation and control of lappaconite hydrobromide injection.

关 键 词：高效液相色谱法 氢溴酸高乌甲素注射液 含量测定 质量控制 

分 类 号：R927.2[医药卫生—药学]