烟台大学学报（自然科学与工程版）2017，Vol.30Issue(3)：202-206,5.DOI:10.13951/j.cnki.37-1213/n.2017.03.006
亲水作用色谱法测定左卡尼汀注射液含量及杂质A
Determination of Content and Impurity A of Levocarnitine Injectionby Hydrophilic Interaction Liquid Chromatography
摘要
Abstract
A method for the determination of the content and impurity A of levocarnitine injection is developed by hydrophilic interaction liquid chromatography.A number of separation parameters are investigated, including pH value, concentration of the buffer, acetonitrile content, flow rate and column temperature.Finally, the XBridge Amide column (4.6 mm × 250 mm, 3.5 μm) is used with a mobile phase consisting of 10 mmol/L ammonium acetate buffer pre-adjusted to pH value of 5.0 and acetonitrile (20∶80).The column temperature is 40 ℃ and the detection wavelength is 205 nm.The methodological validation results show that impurity A can be completely separated from levocarnitine (R>1.5).The calibration curves for levocarnitine and impurity A revealed good linearities in the range of 0.530-3.21 mg/mL, 2.06-82.4 μg/mL, respectively.The average recoveries (n=9) of the above compounds are 100.4% and 101.2%, respectively.The limit of impurity A detection (S/N=3) is 29.0 ng/mL and quantification (S/N=10) is 68.7 ng/mL.It is indicated that this established method can be used for the quality control of levocarnitine injection.关键词
左卡尼汀/亲水作用色谱/含量测定/杂质Key words
levocarnitine/hydrophilic interaction chromatography/determination/impurity分类
医药卫生引用本文复制引用
耿银银,许丽晓,方会超,王莉,刘万卉..亲水作用色谱法测定左卡尼汀注射液含量及杂质A[J].烟台大学学报（自然科学与工程版）,2017,30(3):202-206,5.基金项目
山东省泰山学者基金资助项目(吴子梅). （吴子梅）
