摘要
目的建立左卡尼汀注射液有关物质的HPLC测定方法。方法采用C18色谱柱，以磷酸盐缓冲液（取磷酸11．5ml，加水1900ml，用1mol／L氢氧化钠约100ml调节pH值至2．4），加庚烷磺酸钠1．1g，振摇使溶解-甲醇（90：10）为流动相，检测波长225nm。结果在选定色谱条件下，有关物质与主药完全分离，左卡尼汀最低检出限为10μg／ml，在0．4266～2．9862mg／ml范围内线性关系良好（R=0．9999）。结论本法简便、准确、专属性好，可用于左卡尼汀注射液有关物质的检测。
Objective To establish a method for determination of levocarnitine injection. Methods Shiseido capcell C18 column, with related substances in sodium octanesulfonate 1.1g, which was dissolved in phospate buffer （11.5 ml of phosphoric acid and 1900 ml of water, adjusting pH to 2.4 with about 100 ml of 1 mol/L hydroxide）- methanol （90： 10） as mobile phase. The detective wave-length was 225nm. Results The related substances can be completely seprarated from levocarnitine. For levocarnitine, the detection limit was10 μ g/ml, a linear range of 0.4266-2.9862 mg/ml （R=0.9999） were obtained. Conclusion A simple, accurate and specific method was established for determination of related substances in levocarnitine injection.
出处
《国际医药卫生导报》
2008年第1期73-75,共3页
International Medicine and Health Guidance News
