蛤蚧定喘丸含量测定方法的改进

目的:改进《中国药典》2010年版蛤蚧定喘丸的含量测定方法。方法:采用高效液相色谱法同时测定盐酸麻黄碱和盐酸伪麻黄碱的含量,色谱柱为Waters SunFire C18柱(4.6 mm×150 mm,5μm),流动相为乙腈-0.1%磷酸(4∶96),流量1.0 mL.min-1,检测波长207 nm,柱温25℃。结果:盐酸麻黄碱在0.025 1～0.502μg,盐酸伪麻黄碱在0.025 03～0.500 6μg范围内浓度与峰面积呈良好的线性关系(r=0.999 9),二者平均回收率(n=6)分别为100.3%(RSD=0.75%)、100.9%(RSD=0.79%)。结论:该方法简便、准确,重现性好,可同时测定盐酸麻黄碱和盐酸伪麻黄碱的含量,改进了2010年版《中国药典》该药品的质量控制方法。

Discussion on the Assay Method of Gejie Dingchuan Pills in Chinese Pharmacopoeia 2010 Edition

Objective： To improve the assay method of Gejie Dingchuan Pills in Chinese Pharmacopeia 2010 edition. Methods： RP- HPLC was used to the determination of ephedrine hydrochloride and pseudoephedrine hydroehloride in Gejie Dingehuan Pills simultaneously. The waters SunFire Clscolumn（4. 6 mm × 150 mm, 5 μm）was used and maintained at 25 ℃with the mobile phase consisting of acetonitrile -0. 1% phosphoric acid solution （4： 96）. The flow rate was 1.0 mL · min- 1 and the UV detection wavelength was 207 nm. Results ： The linear ranges of ephedrine hydroehloride and pseudoephedrine hydrochloride were good in the range of 0. 025 1-0. 502 μg and 0. 025 03-0. 500 6 μg respectively （ r = 0. 999 9）. Their recoveries were 100. 3% （ RSD = 0. 75% ） and 100. 9% （ RSD = 0. 79% ） respectively. Conclusion： The improved method was simple, accurate and reproducible, and can be used for the quality control of Gejie Dingchuan Pills.