HPLC法测定扎来普隆分散片的含量及有关物质

目的:建立HPLC法测定扎来普隆分散片的含量及有关物质.方法:采用Agilent TC-C18(2)色谱柱(4.6 mm×250 mm,5μm),流动相为乙腈-0.004 mol·L-1醋酸铵溶液(用醋酸调pH至4.0)(38:62),流速为1.0 mL·min-1,柱温为30℃,检测波长339 nm.结果:在选定的色...

Assay of zaleplon and its related substances in zalepion dispersible tablets by HPLC

Objective:To establish an HPLC method for the assay of zaleplon and its related substances in zaleplondispersible tablets.Methods:The assay was performed on an Agilent TC-C₁₈(2)column(4.6 mm×250 mm,5μm)with a mobile phase of acetonitrile-0.004 mol·L^-1ammonium acetate solution(pH adjusted to 4.0 withacetic acid)(38∶62)at a flow rate of 1.0 mL·min^-1.The column temperature was set at 30℃and the detectionwavelength was 339 nm.Results:The related substances were completely separated from the main constituent.Thelinear range of zaleplon was 6.67-33.33μg·mL^-1(r=0.9999).The average recovery was 100.14%with RSDof 0.14%(n=9).The limit of detection and the limit of quantification of zaleplon were 29.9 ng·mL^-1and99.8 ng·mL^-1,respectively.Conclusion:The method is simple,accurate and sensitive,which can be used tocontrol the quality of zaleplon dispersible tablets.