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目的:建立咽速康气雾剂中胆酸的含量测定方法。方法:利用HPLC-ELSD法,采用Cromasil C18色谱柱(4.6mm×250mm,5μm);流动相甲醇-0.1%冰醋酸水溶液梯度洗脱;漂移管温度75℃;氮气流速33psi。结果:胆酸对照品在0.6542～16.355μg内,进样量与峰面积间的对数值呈良好的线性关系,r=0.9998,平均回收率100.27%,RSD为2.13%。结论:本方法结果准确,重复性好,可作为该制剂的含量测定方法。
Objective: To establish a method for the determination of cholic acid in Yan Fu Kang aerosol. Methods: The HPLC-ELSD method was used on a Cromasil C18 column (4.6 mm × 250 mm, 5 μm). The mobile phase was eluted with a gradient of methanol-0.1% glacial acetic acid. The temperature of the drift tube was 75 ℃. The flow rate of nitrogen was 33 psi. Results: The calibration curve of cholic acid in the range of 0.6542 ~ 16.355μg was linear with the logarithm of the peak area, r = 0.9998. The average recovery was 100.27% and the RSD was 2.13%. Conclusion: The method is accurate and reproducible, and can be used as a method for the determination of the content of the preparation.