反相离子对色谱法测定硫酸沙丁胺醇原料药含量

Determination of sulbutamol sulfate by reverse phase ion-pair HPLC

[目的]建立硫酸沙丁胺醇原料药含量高效液相测定方法。[方法]采用phenomenex ODS 250 mm ×4.6 mm, 5 μm（美国phenomenex公司）。流动相：甲醇：pH5．8磷酸盐缓冲液（含己烷磺酸钠0．1％）=22．5：77．5，流速：1．0ml／min，柱温25℃，检测波长：λ=227m；[结果]硫酸沙丁胺醇方法回收率大于99％，小于102％，在0．198～39．52,ag／ml范围内线相关系数为0．9999，日内、日间RSD均小于3％，重现性良好。[结论]本法简便、准确、灵敏．适用硫酸沙丁胺醇原料药含量测定。

[Objective] To establish RP- HPLC method for the determination of the concentration of sulbutamol sulfate. [Methods] the concentration of salbutamol was analyzed by RP - HPLC. The separation was performed in a phenomenex ODS- C18 （250 mm×4.6 mm, 5 μm） with mobile phase of methanol- pH5.8 buffer solution 0.1% sodium hexanyl sulphonate= 22.5： 77.5. The UV- detector at 227 nm was selected. [Results] The recoveries of salbutamol were more than 99% and less than 102%. The calibration curve was linear over the range of 0. 198 - 39.52 μg/ml with a correlation coefficient of 0.9999. The RSD of in- day and between - day was less than 3%. [Conclusion] The method is simple, precise, accurate and usable for concentration studies of salbutamol.