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建立了高效液相色谱法测定噻托溴铵及其有关物质。使用Diamonsil-C_(18)色谱柱,流动相为0.03 mol/L辛烷磺酸钠溶液(含0.5%三乙胺,用磷酸调至p H 3.3)∶甲醇∶乙腈(50∶20∶30),检测波长238 nm。噻托溴铵与有关物质的分离度良好。噻托溴铵在0.01~1.0 mg/ml范围内线性关系良好,平均回收率为100.1%,RSD为0.16%。
A high performance liquid chromatography was established for the determination of tiotropium bromide and its related substances. The mobile phase consisted of 0.03 mol / L sodium octane sulfonate solution (containing 0.5% triethylamine and adjusted to pH3.3 with phosphoric acid) by using Diamonsil-C18 column. The mobile phase consisted of methanol: acetonitrile (50:20:30) , Detection wavelength 238 nm. Tiotropium bromide and related substances of good separation. Tiotropium bromide had a good linearity in the range of 0.01-1.0 mg / ml with an average recovery of 100.1% and a RSD of 0.16%.