摘要
目的:建立HPLC测定硫酸左旋沙丁胺醇缓释微丸胶囊含量及其有关物质。方法:色谱柱:Chirex(S)-ICA and(R)-NEA(250mm×4.6mm,5μm),流动相:正己烷-二氯甲烷-甲醇-三氟乙酸(240:240:20:1),检测波长:278nm,流速:1ml·min^(-1),柱温:30℃,进样量:20μl。结果:硫酸左旋沙丁胺醇检测浓度的线性范围为1.00～6.03μg(r=0.9995);平均回收率为99.94%(RSD=0.1%)。结论:本方法简便、准确、专属性强,可用于该制剂的质量控制。
Objective ： To establish a method for the determination of content and related substances in L-salbutamol sulphate sustainedrelease pellets capsules by HPLC. Method： HPLC was performed on a Chirex（S） -ICA and （R）-NEA colunmn250 mm ×4. 6 mm,5μm） using hexane- dichloromethane- methanol-trifluoroacetic acid （240： 240： 20：1 ） as the mobile phase at a flow rate of lml·min^-1. The detection wavelength was at 278 nm. The column temperature was 30℃ and the injection volume was 20 μl. Result： The linear range of L-salbutamol sulphate was 1.00-6. 03 μg （r =0. 999 5） ,and the average recovery was 99. 94% （RSD =0. 1% ）. Conclusion： The method is simple,accurate and special which can be used for the quality control of L-salbutamol sulphate sustained-release pellets capsules.
出处
《中国药师》
CAS
2011年第6期816-818,共3页
China Pharmacist
