HPLC-ELSD法测定小儿胃安片中盐酸赖氨酸的含量

Determination of lysine hydrochloride in Xiaoerweian Pian by HPLC-ELSD

目的建立小儿胃安片中盐酸赖氨酸的含量测定方法。方法应用高效液相色谱-蒸发光散射检测仪,DiomonsilC18(250mm×4.6mm,5μm)色谱柱,以乙腈-甲醇-0.1%三氟醋酸溶液(2:1:97)为流动相,流速为0.2ml/min,测定小儿胃安片中盐酸赖氨酸的含量。结果在0.2496￣4.992μg范围内,色谱峰面积对数与对照品量的对数呈良好的线性关系r,=0.9998;平均回收率为98.02%(RSD=1.05%,n=6)。结论该法快速、简便、重现性好,可用于小儿胃安片中盐酸赖氨酸的质量控制。

Objective To establish a method to determine the content of lysine in Xiaoerweian Plan, Methods With high performance liquid chromatography（HPLC）- evaporative light scattering detection （ELSD） ;a diamonsil C18（250mm×4.6mm,5μm） as analytical column. Methanolacetonitrile -0.1TFA （2：1：97） as the mobile phase,and a flow rate of 0.2ml/min,the contents of lysine hydroehloride were analyzed. Results The calibration curves were linear in the range of 0.2496-4.992p, g（ r=0.9998）.The average recovery rates were 98.02%. Conclusion This method is fast,simple and reproducible,and it can be used for assay of lysine hydroehloride in Xiaoeranwei Plan.