高效液相色谱法测定泛酸钠中的有关物质  

Determination of the related substances in D-sodium pantothenate by HPLC

作　　者：黎玲[1] 王东凯[1] 王丽君[1] 杨秀丽[1] 薛梅妍[1] 庄润 

机构地区：[1]沈阳药科大学药学院,沈阳110016 [2]沈阳沃森药物研究所,沈阳110016

出　　处：《中国新药杂志》2006年第3期211-213,共3页Chinese Journal of New Drugs

摘　　要：目的:建立高效液相色谱法检测泛酸钠原料中的有关物质。方法:氨基硅烷键合相色谱柱(300 mm×4．6 mm,5μm);流动相:0．05 mol·L^(-1)磷酸二氢钾溶液-乙腈(30:70),用10%磷酸溶液调节pH为5．8;检测波长: 214 nm;流速:1．5 mL·min^(-1)。结果:杂质峰与主峰能够得到有效的分离,最低检出浓度为10 ng·mL^(-1),3批泛酸钠样品经检测有关物质分别为0．10%,0．08%,0．12%。结论:该法可用于检查泛酸钠原料中的有关物质,简便、准确。Objective：To establish a HPLC method for determination of the related substances in D-sodium pantothenate. Methods： The HPLC condition was as follows： a NH2 column （300 mm × 4.6 mm, 5 μm ）, the mobile phase consisted of 0.05 mol·L^-1 monobasic potassium phosphate solution-acetonitrile （30： 70） （ pH 5.8, adjusted with 10% phosphoric acid） with a flow rate of 1.5 mL·min^-1 and the UV detection at 214 nm. Results：The major components could be satisfactorily separated from the related substances. The detection limit was 10 ng·mL^-1. The impurity rate of three batches of D-sodium pantothenate samples was 0.10% , 0.08% and 0.12% , respectively. Conclusion：The simple and accurate HPLC method could be used in the quality control of D-Sodium pantothenate.

关 键 词：高效液相色谱法 泛酸钠 有关物质检查 

分 类 号：R927.2[医药卫生—药学] R977.22