HPLC法测定扎来普隆分散片的含量及有关物质  

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

作　　者：吴月霞 杨本霞[1] 陈杰[1] WU Yuexia;YANG Benxia;CHEN Jie(Henan Institute for Food and Drug Control,Zhengzhou 450018,China)

机构地区：[1]河南省食品药品检验所,郑州450018

出　　处：《中国药品标准》2022年第1期59-62,共4页Drug Standards of China

摘　　要：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-C_(18)(2)色谱柱(4.6 mm×250 mm,5μm),流动相为乙腈-0.004 mol·L;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:在选定的色谱条件下,主成分峰与各杂质峰之间的分离度良好,扎来普隆在6.67~33.33μg·mL^(-1)的浓度范围内与其峰面积呈良好的线性关系(r=0.9999),平均回收率为100.14%,其RSD=0.14%(n=9)。扎来普隆检出限为29.9 ng·mL^(-1),定量限为99.8 ng·mL^(-1)。结论:所建方法快速简单,专属性强,灵敏度高,可用于扎来普隆分散片的质量控制。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-C_(18)(2)column(4.6 mm×250 mm,5μm)with a mobile phase of acetonitrile-0.004 mol·L^(-1)ammonium 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^(-1)and99.8 ng·mL^(-1),respectively.Conclusion:The method is simple,accurate and sensitive,which can be used tocontrol the quality of zaleplon dispersible tablets.

关 键 词：扎来普隆分散片 有关物质 含量测定 高效液相色谱法 

分 类 号：R921.2[医药卫生—药学]