中国当代医药Issue(19)：8-12,20,6.
高效液相色谱法测定左卡尼汀注射液的含量及杂质A
Content and impurity A of levocarnitine injection determined by high per-formance liquid chromatography
袁彩君 1朱天新2
作者信息
- 1. 河南省驻马店市中心医院药剂科，河南驻马店 463000
- 2. 河南欣泰药业有限公司，河南驻马店 463000
- 折叠
摘要
Abstract
Objective To establish a high performance liquid chromatography (HPLC) method determining the content and impurity A of levocarnitine injection selecting anion chromatographic column as separation medium. Methods The column was PhenoSphere 5u SAX 80A (250í4.60 mm) and the column temperature was 30 ℃.The mobile phase was the ratio of acetonitrile and phosphate solution (potassium dihydrogen phosphate of 6.81 g/L regulated by sodium hy-droxide solution with the pH of 4.7) was 65:35.The detection wavelength was 205 nm and injection volume was 20 μl. The flow velocity was 1.0 ml/min and the outcome were calculated by external standard method. Results Levocarnitine and impurity A was effectively separated,and the degree of separation was over 1.5.Determination was not interfered by adjuvant material or mobile phase.The limit of detection (LOD) and limit of quantitation (LOQ) of levocarnitine was 0.5μg/ml and 2 μg/ml respectively.The LOD and LOQ of impurity A in levocarnitine was 20 ng/ml and 50 ng/ml respectively. Ranging from 1034 to 8274μg/ml,levocarnitine displayed a good linear relationship (r2=0.99996).Ranging from 0.25 to 25 μg/ml,impurity A displayed a good linear relationship (r2=0.99987).The average recovery rate of levocarnitine and impurity A was 101.29%(RSD=0.55%) and 100.35%(RSD=1.79%). Conclusion The established method is specific,ac-curate and convenient,which can be used for the determination of content and impurity A in levocarnitine injection.关键词
左卡尼汀注射液/左卡尼汀/杂质A/高效液相色谱法/测定Key words
Levocarnitine injection/Levocarnitine/Impurity A/High performance liquid chromatography/Determination分类
医药卫生引用本文复制引用
袁彩君,朱天新..高效液相色谱法测定左卡尼汀注射液的含量及杂质A[J].中国当代医药,2015,(19):8-12,20,6.
