摘要
目的:建立高效液相色谱-示差折光检测器法测定氨糖美辛肠溶片中盐酸氨基葡萄糖含量。方法:使用Waters XBridge Amide(4.6 mm×250 mm,3.5μm)色谱柱,流动相:80%乙腈溶液(1000 mL中含1 mL氨水),流速:1.2 mL•min^(-1);柱温:40℃;进样量:20μL,示差折光检测器(RID)检测。结果:盐酸氨基葡萄糖检测限为0.03 mg•mL^(-1),定量限为0.125 mg•mL^(-1),其在0.72~7.56 mg•mL^(-1)质量浓度范围内呈良好的线性关系。平均回收率为99.36%(RSD=0.85%,n=9)。测定氨糖美辛肠溶片7批,盐酸氨基葡萄糖的含量在93%~107%范围内。结论:所建方法检测快速准确、专属性强、耐用性较好,可用于盐酸氨基葡萄糖含量的测定,为有效控制氨糖美辛肠溶片的质量提供参考。
Objective:To establish a method for the determination of glucosamine hydrochloride content in aminoglycine enteric coated tablets by high-performance liquid chromatography with differential refractive detector.Methods:Waters XBridge Amide(4.6 mm×250 mm,3.5μm)column was used.The mobile phase was 80%acetonitrile solution(1000 mL containing 1 mL ammonia)at the flow rate of 1.2 mL•min^(-1).Column temperature was set on 40℃;Injecting volume was 20μL with differential refraction detector(RID)detection.Results:The detection limit of glucosamine hydrochloride was 0.03 mg•mL^(-1),and the limit of quantification was 0.125 mg•mL^(-1).It showed a good linear relationship in the mass concentration range of 0.72-7.56 mg•mL^(-1).The average recovery was 99.4%(RSD=0.85%,n=9).The content of glucosamine hydrochloride in 7 batches of aminosamine enteric-coated tablets was measured in the range of 93%-107%.Conclusion:The proposed method is fast,accurate,specific and durable,and can be used for the determination of glucosamine hydrochloride,which provides a reference for effectively controlling the quality of aminoxymetacin enteric-coated tablets.
作者
袁进烨
陈琦
薛巧如
陈华
YUAN Jinye;CHEN Qi;XUE Qiaoru;CHEN Hua(Guangdong Institute for Drug Control,Guangzhou 510663,China)
出处
《中国药品标准》
CAS
2024年第1期62-67,共6页
Drug Standards of China
基金
广东省药品检验所所内项目(SN2022003)。
