摘要
目的：建立简便快捷的左卡尼汀注射液含量及有关物质测定方法。方法：采用AlltechBrava Amino色谱柱（250 mm×4.6 mm,5μm）,柱温40℃,以0.01 mol·L^-1磷酸盐缓冲液-乙腈（25∶75）为流动相,流速1.0 mL·min^-1,检测波长205 nm。结果：左卡尼汀与各有关物质及降解产物色谱峰分离度良好,各杂质峰互不干扰。左卡尼汀、杂质A、杂质B、杂质C、杂质D质量浓度分别在436.2～2 617、3.5～87.4、2.8～56、1.79～44.8、2.54～50.8μg·mL^-1范围内线性关系良好,平均回收率（n=9）分别为100.0%、100.1%、101.6%、95.7%和102.5%,其定量限（S/N=10）分别为167.50、4.20、22.40、60.48和30.48 ng。结论：方法学验证结果表明,本法可用于左卡尼汀注射液的质量控制。
Objective： To establish an HPLC method for the determination of the content and related substances of levocarnitine injection. Methods： The AlltechBrava Amino column（ 250 mm × 4. 6 mm,5 μm） was used with a mobile phase consisting of 0. 01 mol·L^-1potassium dihydrogen phosphate buffer solution and acetonitrile（ 25∶ 75） at a flow rate of 1. 0 mL·min^-1. The detection wavelength was 205 nm and the column temperature was 40 ℃. The injection volume was 10 μL. Results： The related substances and degraded products were completely separated from levocarnitine. And an excellent separation was achieved for the related substances. The calibration curves for levocarnitine,impurity A,impurity B,impurity C and impurity D revealed good linearities in the range of 436. 2-2 617 μg·mL^-1,3. 5-87. 4 μg·mL^-1,2. 8-56 μg·mL^-1,1. 79-44. 8 μg·mL^-1,2. 54-50. 8 μg·mL^-1,respectively.The average recoveries（ n = 9） of the above compounds were 100. 0%,100. 1%,101. 6%,95. 7% and 102. 5%,respectively. The limits of quantification（ S / N = 10） of these compounds were 167. 50 ng,4. 20 ng,22. 40 ng,60. 48 ng and 30. 48 ng respectively. Conclusion： The methodological validation results indicate that the established method can be applied to quality control of levocarnitine injection.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2015年第2期301-305,共5页
Chinese Journal of Pharmaceutical Analysis
基金
北京中医药大学自主选题项目(2014-JYBZZ-JS-023)
