阿卡波糖口服固体制剂含量测定方法的优化  

Optimization of content determination of acarbose oral solid preparation

作　　者：石笑弋 易必新 李昌亮 李帅 刘雁鸣 兰文 李健和[3] SHI Xiao-yi;YI Bi-xin;LI Chang-liang;LI Shuai;LIU Yan-ming;LAN Wen;LI Jianhe(Hunan Institute for Drug Control and Testing,Changsha 410001;NMPA Key Laboratory for Pharmaceutical Excipients Engineering Technology Reasearch,Changsha 410001;Department of Pharmacy,Second Xiangya Hospital,Central South University,Changsha 410011)

机构地区：[1]湖南省药品检验检测研究院,长沙410001 [2]国家药品监督管理局药用辅料工程技术研究重点实验室,长沙410001 [3]中南大学湘雅二医院药学部,长沙410011

出　　处：《中南药学》2022年第6期1404-1406,共3页Central South Pharmacy

基　　金：2021年国家药品抽验计划(No.国药监药管[2021]1号)。

摘　　要：目的建立一种新的高效液相色谱法测定阿卡波糖的含量。方法采用Welch Ultimate XB-SCX色谱柱(4.6 mm×250 mm,3μm),流动相为0.02 mol·L^(-1)磷酸二氢钾溶液,流速1.0 mL·min^(-1),柱温40℃,检测波长210 nm。结果阿卡波糖在82.60~4130μg·mL^(-1)与峰面积线性关系良好(r=1.000),平均回收率为99.41%,RSD为0.32%(n=6)。结论该方法准确、可靠、重复性好,可作为阿卡波糖口服固体制剂质量控制和评价的新方法。Objective To establish a HPLC method to determine the content of acarbose.Methods The column of Welch Ultimate XB-SCX(4.6 mm×250 mm,3μm)was used.The mobile phase was 0.02 mol·L^(-1)potassium dihydrogen phosphate.The flow rate was 1.0 mL·min^(-1).The column temperature was 40℃.The detection wavelength was 210 nm.Results Acarbose showed a good linearity at 82.60-4130μg·mL^(-1)(r=1.000).The average recovery was 99.41%,and RSD was 0.32%(n=6).Conclusion The method is accurate,reliable and repeatatble,which can be used to evaluate and control the quality of acarbose oral solid preparation.

关 键 词：阿卡波糖 含量测定 高效液相色谱法 SCX色谱柱 

分 类 号：R917[医药卫生—药物分析学]