HPLC法测定苦参素注射液中枸橼酸含量  

Determination of Citric Acid in Kushensu Injection by HPLC

作　　者：罗嵚[1,2] 谢敏[2] 吴春敏[2] 

机构地区：[1]福建中医药大学,福州350108 [2]福建省药品检验所,福州350001

出　　处：《海峡药学》2012年第5期38-40,共3页Strait Pharmaceutical Journal

摘　　要：目的建立苦参素注射液中枸橼酸的高效液相色谱检测方法。方法采用Eclipse XDB-C18色谱柱(4.60×150mm,5μm),以乙腈-0.02mol·L-1磷酸二氢钾(含0.2%辛烷磺酸钠,用磷酸调节pH至2.5)为流动相进行梯度洗脱,检测波长为210nm,流速为0.5mL.min-1。结果枸橼酸在0.04356mg·mL-1～1.089mg·mL-1范围内线性关系良好(r=1),平均回收率为100.0%。结论该方法简便、准确、灵敏、重复性好,可作为该制剂质量控制方法。OBJECTIVE To develop an HPLC method for determination of Citric Acid in Matrin Injection.METHODS The HPLC was performed on a Eclipse XDB-Ct8 column（4.60 × 150mm, 5μm）, the mobile phase was acetonitrile-0.02mol· L- 1 potassium dihydrogen phosphate （0.2 % 1-octane sulfonic acid sodium salt, adjusted to pH 2.5 with phosphoric acid）, the detection wavelength was 210nm, the flow rate 0.5mL·min-1 ~ RESULTS The Citric Acid linear range was 0. 04356mg·mL- 1 1.089mg· mL- t, and the average recovery was 100.0 %. CONCLUSION The method is convenient, accurate, sensitive and repeatability, which can be used to as a quality control method for Matrin Injection.

关 键 词：HPLC 枸橼酸 含量 苦参素注射液 

分 类 号：R927.2[医药卫生—药学]