高效毛细管电泳法测定肌肽含量方法的研究

目的建立肌肽原料药的含量测定和杂质检查方法,为其质量控制提供快速、有效的分析手段。方法色谱柱为河北永年光导纤维厂的未涂层石英毛细管（75 m I.D.×65 cm）,流动相：100 mmol.L-1 Na2B4O7-H3BO3缓冲溶液,重力进样,检测波长为200 nm。考察了不同流动相下药物的色谱峰,同时进行了专属性、线性关系、精密度等项的考察。结果肌肽在在40.0～100.0 g.mL-1范围内线性关系良好（r=0.9991）,RSD为1.2%,最低检测限为2 ng。相关杂质、中间体与肌肽分离良好。结论该法专属性强,结果准确,重现性好,可用作肌肽含量测定和相关物质控制的方法。

Study of High Performance Capillary Electrophoresis in the Determination of Carnosine Content

Objective To establish the methods for the content determination of carnosine bulk drugs and impurity examination so as to provide a fast and efficient analytical tool for its quality inspection.Methods The conditions were：color column（75 m I.D.×65 cm）：uncoated silica capillary tube,produced by Hebei Yongnian Optical Fiber Factory;mobile phase：100 mmol·L-1;buffer solution：Na2B4O7-H3BO3;gravity injection,detection wavelength：200 mn.The peaks under different mobile phases were investigated,as well as the specificity,linearity,precision,etc.Results Carnosine presented a good linear relationship（r=0.9991）in the range from 40.0 to 100.0 g·mL-1.RSD was 1.2% and the lowest detection limit was 2ng.The relevant impurities,intermediates and carnosine were well separated with each other.Conclusion This method is strong in specificity,accurate in result and good in reproducibility.This method can be applied for carnosine content determination and relevant substance control.