HPLC法测定左卡尼汀注射液中的含量及有关物质A  

Determination of the content and related compound A in Levocarnitine injection by HPLC

作　　者：李红英 于得才 

机构地区：[1]山东威高药业有限责任公司,威海264210 [2]内蒙古库伦蒙药厂,通辽028200

出　　处：《北方药学》2015年第1期2-4,共3页Journal of North Pharmacy

摘　　要：目的：建立HPLC法测定左卡尼汀注射液中的含量及有关物质A。方法：色谱柱：硅胶为填充剂（250mm×4.6mm,5um）;乙腈∶磷酸盐缓冲液（0.05mol/L磷酸氢二钠,用稀磷酸调p H值为5.50）=60∶40为流动相;检测波长为205nm;流速为1.0ml/min。结果：左卡尼汀在28.16~52.30μg范围内呈良好的线性关系,r=0.9999;平均回收率（n=6）为99.70%,RSD=0.51%;有关物质A在8.11~243.36ng范围内呈良好的线性关系,r=1.0000;平均回收率（n=6）为100.07%,RSD=0.36%。结论：本法简单、准确、重复性好、区分力强,可作为左卡尼汀注射液的质控方法。Objective To establish a HPLC method for determination of the content and related compound A in Levocarnitine injection.Methods A column of silicagel column was adopted;and the mobile phase was the mixture of acetonitrile-phosphate buffer（0.05mol/Lsodium hydrogen phosphate,with phosphoric acid to adjust p H 5.5）=60 ∶40;The detection wavelength was set at 205nm;the flow rate was 1.0ml/min.Results Levocarnitine showed a good linear relationship in the range of 28.16~52.30μg（r=0.9999）;The average recovery（n=6）was 99.70%（RSD=0.51%）;The related compound A of Levocarnitine showed a good linear relationship in the range of 8.112~243.36 ng（r =1.0000）;The average recovery（n =6） was 100.07%（RSD =0.36%）. Conclusion The method is simple,accurate and reproducible,which can be uses for the quality control of Levocarnitine injection.

关 键 词：左卡尼汀注射液 高效液相色谱 含量 有关物质A 

分 类 号：R927.2[医药卫生—药学]