高效液相色谱法测定盐酸氨溴索口腔崩解片的含量和有关物质  

Determination of Contents and Related Subtances in Ambroxol Hydrochloride Orally Disintegrating Tablets by HPLC

作　　者：付建 赵海桥 苏贵勇 赵永娟 

机构地区：[1]山东方明药业集团股份有限公司,山东菏泽274500

出　　处：《食品与药品》2014年第5期340-343,共4页Food and Drug

摘　　要：目的 建立高效液相色谱法（HPLC）测定盐酸氨溴索口腔崩解片含量和有关物质的方法。方法 采用Phenomenex Luna C18（2）（4.6 mm×250 mm,5μm）色谱柱,以0.01 mol/L磷酸氢二铵溶液（用磷酸调pH 7.0）-乙腈（50：50）为流动相;检测波长248 nm;流速1.0 mL/min。结果 盐酸氨溴索在12.04~42.14μg/mL范围内,峰面积与浓度的线性关系良好（r=0.9998）,平均回收率为99.8%,RSD为0.62%（n=9）。结论 此法准确、简便、快速,适用于盐酸氨溴索口腔崩解片的质量控制。Objective To establish a method for determination of the contents and related subtances in Ambroxol Hydrochloride Orally Disintegrating Tablets. Methods The Phenomenex Luna C18（2）（4.6 mm×250 mm, 5 μm） was adopted. The mobile phase was 0.01 mol/L （NH4）2HPO4（adjusted to pH 7.0 with phosphoric acid）- acetonitrile（50：50） with the flow rate of 1.0 mL/min. The wavelength used for detection was 248 nm. Results A good linear relationship（r=0.9998） was obtained in the concentration of 12.04-42.14 μg/mL. The average recovery was 99.8 %, with RSD of 0.62 % （n=9）. Conclusion The method is accurate, simple, rapid, and can be used in quality control.

关 键 词：盐酸氨溴索 口腔崩解片 含量测定 有关物质 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]