HPLC法测定防风通圣颗粒中盐酸麻黄碱和盐酸伪麻黄碱含量

Determination of Ephedrine Hydrochloride and Pseudoephedrine Hydrochloride in Fang Feng Tong Sheng Granules by HPLC

目的建立防风通圣颗粒中盐酸麻黄碱和盐酸伪麻黄碱的含量测定方法。方法高效液相色谱法,采用Synergi 4u Polar-RP 80A色谱柱;流动相:乙腈-0.02mol·L^(-1)磷酸二氢钾溶液(含0.3%三乙胺,用磷酸调节p H值至3.0)(4∶96);流速:1.0m L·min^(-1),检测波长:210nm,柱温:35℃。结果盐酸麻黄碱在0.1218~0.6090μg(r=0.9998)、盐酸伪麻黄碱在0.0818~0.4088μg(r=0.9992)的范围内呈良好的线性关系,平均回收率盐酸麻黄碱为99.41%,RSD为0.55%(n=9)、盐酸伪麻黄碱为99.65%,RSD为0.55%(n=9)。结论本方法准确、灵敏度高、重现性好,可用于防风通圣颗粒中盐酸麻黄碱和盐酸伪麻黄碱的质量控制。

OBJECTIVE To create a determination method for the active fraction of ephedrine hydrochloride and pseudoephedrine hydrochloride in FangFengTongSheng Granules. METHODS HPLC, Synergi 4u Polar-RP 80A （ 250mm× 4. 6mm, 5 μm） ; mobile phase ： acetonitrile： 0. 02mol · L - 1 potassium dihydrogen phosphate （ 4： 96 ） ; flow rate：1. 0mL · min-1 ;detection wavelength：210nm;temperature：35℃. RESULTS The calibration curve of ephedrine hydrochloride and pseudoephedrine hydrochloride was in good linearity over the range of 0. 1218 ～0. 6090μg（ r = 0. 9998 ） and 0. 0818 ～ 0. 40881μg（ r = 0. 9998 ）. The mean recoveries respective of ephedrine hydrochloride was 99.41%, （RSD = 0. 55%, n = 9 ） and pseudoephedrine hydrochloride was 99.65% （RSD = 0. 55%, n = 9 ） .CONCLUSION The method is accurate, reliable and reproducible, and it can be used for the quality control of ephedrine hydrochloride and pseudoephedrine hydrochloride in the the active fraction FangFengTongSheng Granules.