紫外分光光度法测定注射用西维来司他钠的含量

Assay of sivelestat sodium hydrate for injection by UV spectrophotography

目的建立紫外分光光度测定注射用西维来司他钠含量的方法。方法据中国药典2005年版二部附录ⅣA，以0．01mol·L^-1氢氧化钠甲醇溶液为溶剂。测定波长325nm。结果在10～150μg·mL^-1浓度范围内，吸收度-5相应的浓度呈良好的线性关系（r=0．9999）。重复测定吸收度平均值为0.4441（n=6）．相对标准偏差为0．46％。平均回收率为99．9％（n=9），相对标准偏差为0.6％。结论本方法结果稳定，重复性好。为注射用西维来司他钠提供了一个简单方便的含量测定方法。

OBJECTIVE To establish the assay method for sivelestat sodium hydrate for injection by UV spectrophotography.METHODS According to the Appendix Ⅳ A in Chinese Pharmacopeia 2005, 0.01mol·L^-1 sodium hydroxide methanol was used as solvent, and detected at the wavelength of 325nm. RESULTS There was a quite good linear relationship between adsorption value and the concentrations （r= 0. 9999）during 10-150μg·mL^-1.The mean adsorption value was 0.4441 and RSD was 0.46% by the repeat determination （n= 6）.The mean recovery rate was 99.9 % （n = 9）, and the RSD was 0.6 %. CONCLUSION The results of this method are stable and have good repeatability. It provides an easy method for the content determination of sivelestat sodium hydrate for injection.