HPLC法测定清肺消炎丸中盐酸麻黄碱的含量

HPLC Determination of Ephedrine Hydrochloride Content in Qingfei Xiaoyan Pill

目的：建立HPLC法测定清肺消炎丸中盐酸麻黄碱含量的方法。方法：色谱柱：Phenomenex GEMINI C18（5μm，4．6mm×250mm）；流动相：乙腈-0．02mol·L^-1磷酸二氢钾溶液（磷酸调pH值至2．7）（4：96）；检测波长：207nm；柱温：30℃；流速：1．0mL·min^-1。结果：线性范围为0．0416～0．6656μg（r=0．9999），平均回收率为99．71％，RSD为0．75％，重复性RSD为1．12％（n=6），精密度RSD为1．27％（n=6），稳定性RSD为0．80％。结论：本文所得方法稳定、可靠，可作为该制剂的质量控制方法。

Authors established an HPLC method to determine Ephedrine hydrochloride content in Qingfei Xiaoyan Pill. In the study, Ephedrine hydrochloridein were assayed on a Phenomenex GEMINI C18（5μm, 4.6mm×250mm）column, with the mobile phase composed of Acetonitrile-0.02mol·L^-1 KH2PO3 solution （adjusted to PH=2.7 with phosphoric acid） （4： 96） at a flow rate of 1.0 ml·min^-1. The determination wavelength was defined at 207 nm. Results show linear calibration curves were ranged from 0.0416μg to 0.6656μg （r = 0.9999）for Ephedrine hydrochloridein. The averaged recovery （n=6） of Ephedrine hydrochloridein was 99.71% （RSD=0.75%）. The method has been proved simple, reliable, accurate, and repeatable, and is effective for the quality control of Qingfei Xiaoyan Pill.