| Objectives:I) To establish new methods for simultaneously separating and determining ephedrine alkaloids, paracetamol and chlorpheniramine in complex matrix by micellar high performance liquid chromatography. Try to deal with the problems that often occurs when alkanoids compounds are separated by high performance liquid chromatography based on silica stationary phase, such as peaks tailing, separation difficulty for basic analytes with similar chemical structures, complex sample pretreatment process and so on. To provide alternative methods for pharmacokinetics studies and the quality controlling of the herbal medicine and its preparations which contain these active pharmaceutical ingredients.2) Try to uncover the possible separation mechanism of the proposed micellar high performance liquid chromatography for the separation of the analytes by investigating the factors that affect the chromatographic behaviors. To build a model to mimic the separation process and to well understand the interaction among the analytes and stationary phase and micellar phase.Methods:To obtain optimized conditions for the separation of ephedrine alkaloids in Ephedra Herb and its preparations, and the active constituents of the cold compound preparations (pseudoephedrine, paracetamol and chlorpheniramine). single rotation method was used to investigate the factors that affect the chromatographic behaviors, such as the types of chromatographic column, the types of surfactant and its concentration, the types of organic modifier and its proportion, pH of the mobile phase, column temperature and flow rate. Based on the results of optimized chromatographic conditions, novel micellar high performance liquid chromatographic methods for simultaneously separaing and determining the contents of these active pharmaceutical ingredients were established, and the possible separation mechanisms were investigated and the separation models were also developed. Results:The proposed novel micellar high performance liquid chromatographic methods for simultaneous separation and determination of ephedrine, pseudoephedrine and methylephedrine in Ephedra Herb and its preparations, human serum after oral administration of Kechuanning Koufye and pseudoephedrine, paracetamol and chlorpheniramine in the cold compound preparations have been developed, respectively. The separation mechanism for the separation of these analytes by the proposed MHPLC was investigated.Conclusions:The proposed micellar high performance liquid chromatographic methods were simple, "green",accurate and low price, which provide new methods for the monitoring of drug concentration in blood in clinic and also provide new alternative for the quality controlling of cold medicines, ephedrine and its preparation. |