RP-HPLC法测定左卡尼汀片中左卡尼汀杂质A  

Determination of levocarnitine impurity A in Levocarnitine Tablets by RP-HPLC

作　　者：刘欢[1] 杨宏丽[2] 丁一[1] 王成港[1] 

机构地区：[1]天津药物研究院天津市药物制剂工程技术研究中心,天津300193 [2]沈阳协合生物制药股份有限公司,辽宁沈阳110179

出　　处：《现代药物与临床》2013年第3期334-337,共4页Drugs & Clinic

摘　　要：目的建立反相高效液相色谱法测定左卡尼汀片中已知杂质左卡尼汀杂质A。方法色谱柱为Waters μBondapakTM NH2(300mm×3.9mm,10μm);流动相为0.05mol/L磷酸二氢钾溶液(用稀磷酸调节pH值4.0)-乙腈(35∶65);体积流量1.0mL/min;检测波长为205nm;进样量20μL;柱温为30℃,外标法计算。结果片剂中左卡尼汀杂质A与左卡尼汀能够完全分离,空白辅料不干扰测定,左卡尼汀杂质A在5.01～75.15μg/mL线性关系良好(r=1.000)。左卡尼汀杂质A平均回收率为100.8%(RSD=1.16%,n=9)。结论经方法学考察,左卡尼汀片中已知杂质左卡尼汀杂质A测定方法的专属性强,准确可靠,易于操作。左卡尼汀片中已知杂质左卡尼汀杂质A的量较低并且稳定。Objective To develop a RP-HPLC method to determine levocarnitine impurity A in Levocarnitine Tablets.Methods The chromatographic conditions included Water μBondapakTM NH2 column（300 mm × 3.9 mm,10 μm）and 0.05 mol/L KH2PO4（adjusted to pH 4.0 with diluted phosphoric acid）-acetonitrile（35：65）as the mobile phase at a flow rate of 1.0 mL/min,detected at 205 nm,injection volume was 20 μL,and the column temperature was 30 ℃,using external standard method to calculate.Results Impurity A and levocarnitine could be completely separated,and blank recipients did not influence the determination.There was a good linearity in the range of 5.01 — 75.15 μg/mL（r = 1.000）.The average recovery of levocarnitine impurity A was 100.8%（RSD = 1.16%,n = 9）.Conclusion The established method is high selective,simple,and accurate.Amount of levocarnitine impurity A is little and stable in Levocarnitine Tablets.

关 键 词：左卡尼汀片 左卡尼汀 左卡尼汀杂质A 高效液相色谱 外标法 

分 类 号：R927.2[医药卫生—药学]