HPLC法测定羟萘甲酸沙美特罗气雾剂含量

目的建立羟萘甲酸沙美特罗气雾剂药物含量测定的方法。方法采用HPLC法。色谱柱为Hypersil C18柱(250 mm×4.6 mm,5μm),流动相为甲醇乙腈水冰醋酸三乙胺(体积比为50∶20∶30∶0.07∶0.05),流速1.0 mL.min-1,紫外检测波长225 nm,室温测定。结果在选择的色谱条件下,理论塔板数以沙美特罗峰计为3 520,沙美特罗保留时间为7.5 min,辅料不干扰药物的测定。沙美特罗质量浓度在20~120 mg.L-1内,线性关系良好(r=0.999 8),平均回收率在99%以上,日内日间RSD均小于2%,重复性小于0.5%。稳定性试验表明,样品溶液稳定性良好。结论本方法可用于羟萘甲酸沙美特罗气雾剂的质量控制。

Determination of content of salmeterol xinafoate in aerosol by HPLC

Objective To establish a HPLC method for determination of salmeterol xinafoate in aerosol.Methods The chromatographic separation was performed on a Hypersil column(250 mm×4.6 mm,5 μm) with UV detection at 225 nm by isocratic elution of mobile phase with flow rate of 1.0 mL·min~(-1).The mobile phase was consisted of methanol-acetonitrile-water-acetic acid-triethylamine(V∶V∶V∶V∶V=50∶20∶30∶0.07∶0.05).The determination was operated at room temperature.Results The theoretical plate number was 3 520 based on the chromatogram of salmeterol.The retention time of salmeterol was 7.5 min and the excipient had no interference with the determination of salmeterol.The calibration curve was linear(r=0.999 8) within the range of 20-120 mg·L~(-1) for salmeterol,the recovery was higher than 99%.The RSD of inter-day and intra-day was under 2%.The repetition RSD was under 0.5% and the samples prepared were stable.Conclusions The described method is simple,accurate,rapid and applicable for routine quality control analysis of salmeterol xinafoate in aerosol.