Research Progress on Analytical Methods for Relative Molecular Weight and Its Distribution of Polymeric Pharmaceutical Excipients
Relative molecular weight and its distribution are important functionality-related characteristics for polymeric pharmaceutical excipients.They are closely related to many properties of polymeric excipients,such as the solubility,mechanical and rheological properties.Many methods have been developed to determine the relative molecular weight and its distribution,including end-group analysis,viscosity method,field flow fractionation and size exclusion chromatography(SEC).The former three traditional methods have certain limitations in applications due to the range and the type of relative molecular weight.SEC is a new liquid chromatographic technique based on volume exclusion separation,and it has gradually become an effective technique for determination of relative molecular weight and molecular weight distribution of polymeric pharmaceutical excipients due to its advantages of high separation efficiency,high accuracy,simple operation and easy automation.In this study,the characteristics and applications of the SEC technique to the determination of relative molecular weight and its distribution of polymeric pharmaceutical excipients are summarized.