HPLC测定胚宝胶囊的含量

Content Determination of Pei-bao Capsule by HPLC

目的建立HPLC测定胚宝胶囊质量的方法。方法采用HPLC测定经用2,4-二硝基氟苯衍生化后的盐酸赖氨酸的含量，色谱柱：agilent Zorbax SB—C18柱（250mm×4．6mm，5μm）；流动相：乙腈-0．04mol／L磷酸二氢钾溶液（40：60）；流速：1．0ml／min;柱温：30℃；检测波长：360nm。结果盐酸赖氨酸浓度在0．39-19．3μg／ml范围内有良好的线性关系（7=0．9999）平均加样回收率为100．2％。结论本方法操作简便、结果准确、重现性好，可作为该产品的质量控制方法。

Objective To establish a HPLC method for quality control of Pei-bao capsule. Methods The content of lysine derivatized from 2,4-dinitoflruorobenzene was determined by HPLC, with chromatographic column being the agilent Zorbax SB-C18 column （250 mm×4.6 mm, 5 μm） , mobile phase being acetonirile-0.04mol/L, potassium dihydrogen phosphate （40 ： 60）, the flow rate being 1.0 ml/min, the column temperature being 30 ℃, and wavelength being 360 nm. Results It showed good linear coorelation when the concentration of Lysine hydrochloride being within 0.39-19.3 μg/ml （ y =0.9999） , and the average sample recovery rate was 100.2%. Conclusion This method is simple, accurate, stable and reliable. It can be used for quality control of Pei-bao capsule.