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

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。

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

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.