动态改性液相色谱法在复方沙丁胺醇双层片质量控制中的应用

Application of Dynamically-modified High Performance Liquid Chromatography in Quality Control of Compound Salbutamol Double-layered Tablets

在ＳｐｈｅｒｉｓｏｒｂＳｉＯ２柱上，甲醇—水—冰醋酸（４０６００．４）为流动相，动态改性色谱法选择分离复方沙丁胺醇双层片中硫酸沙丁胺醇和富马酸酮替芬。考察了色谱体系中各因素对色谱保留的影响。该法用于制剂的含量测定、含量均匀度和有关杂质的检查，取得良好效果。

A dynamically-modified HPLC method was developed for the determination of salbutamol sulphate and ketotifen fumarate in compound salbutamol double-layered tablets.On a Spherisorb SiO 2 column,satisfactory separation of salbutamol sulphate,ketotifen fumarate and related substances was obtained by using methanol-H 2O-glacial acetic acid(40∶60∶0 4) as mobile phase.The influence of column packing,methanol and glacial acetic acid concentration on chromatographic retention was also investigated.This method has been applied to control the quality of the dosage form.