硫酸沙丁胺醇口服结肠定位缓释片的含量测定

Determination of Salbutamol Sulfate oral colon-targeted sustained-release tablet

目的:建立硫酸沙丁胺醇口服结肠定位缓释片的含量测定方法。方法:采用高效液相色谱法进行含量测定。以C18为色谱柱,以磷酸二氢钠溶液-甲醇(85∶15)用磷酸调节pH=3.10±0.05做流动相,检测波长为276 nm。结果:含量测定方法精密度RSD为0.63%,硫酸沙丁胺醇在16～112μg/ml范围内,峰面积与浓度呈良好的线性关系,r=0.999 7,回收率99.49%;本品含量符合要求。结论:含量测定方法准确、灵敏、可靠,可以有效控制本品的质量。

Objective： To set up a method on the determination of Salbutamol Sulfate oral colontargeted sustained-release tablet. Methods： HPLC was used to determine content. Kromasil-C18 column was used, with the mobile phase of sodium dihydrogenphosphate solution-methanol （85：15） and pH was adjusted to 3.10±0.05 by phosphoric acid, detection wavelength was 276 nm. Results： Salbutamol Sulfate had a precision of 0.63% ;when the concentration varied between 16 and 112μg/ml, the peak area showed a good linear correlation with the concentration, r =0.999 7; Recovery rate was 99.49%; Content of Salbutamol Sulfate was complied with the standard. Conclusion： The method is accurate, sensitive and reliability, which can be used to control the quality of Salbutamol Sulfate oral colon-targeted sustainedrelease tablet.