HPLC测定奥替溴铵片中奥替溴铵的含量及有关物质

Determination of Otilonium bromide and its related substances in Otilonium bromide tablets by HPLC

目的 建立奥替溴铵片有关物质检查及其含量测定的方法。方法采用HPLC法，色谱柱为Diamonsil ODS—C18柱（200mm×4．6mm。5μm），流动相为0．3mol·L^-1三水合醋酸钠缓冲液（含3mmol·L^-1庚烷磺酸钠）-乙腈-甲醇（30：70：20,pH6．0）。检测波长293nm。结果 制剂中辅料对主药测定无干扰，奥替溴铵与有关物质可完全分离，在10—100μg·ml^-1。范围内峰面积与浓度呈良好的线性关系。方法精密度（RSD=0．5％）良好，平均回收率为100．3％。结论 所用方法简便、准确、专属性强，可用于奥替溴铵片的含量测定及有关物质的检查。

OBJECTIVE To establish an HPLC method for determining the content and related substances of Otilonium bromide tablets. METHODS Diamonsil ODS- C18 column （200 mm ×4.6 mm, 5 μm） was used. The mobile phase was sodium acetate trihydrate buffer（0.3 mol·L^-1 ） containing 3 mmol· L^- 1 heptanesulfonic acid monohydrate sodium mixed - acetonitrile - methanol （ 30 ： 70 ： 20, pH6.0 ）. The detective wavelength was 293 nm. RESULTS The excipients did not interfere with the determination of Otilonium bromide. Otilonium bromide and its related substance could be completely separated. The linear range of Otilonium bromide was 10 - 100 μg·ml^-1. The precision of the method （RSD =0.5% ）was good. The average recovery was 100.3%. CONCLUSION The method is simple, accurate, specific. It can be used for the content determination and examination of the related substances in Otilonium bromide tablets.