青霉素类药物聚合物检测方法研究  

Study on the Detection Method of Penicillin Drug Polymers

作　　者：朱大明[1] 蒋琦[1] Zhu Daming;Jiang Qi(Food and Drug Inspection Institute of Anshan City,Liaoning,114006)

机构地区：[1]鞍山市食品药品检验所,辽宁114006

出　　处：《当代化工研究》2017年第12期137-138,共2页Modern Chemical Research

摘　　要：目的:《中国药典》2010年版二部中阿莫西林胶囊高分子聚合物测定方法的方法学验证。方法:采用高效液相色谱法中分子排阻方法,进样量:100μl。结果:高聚体检测精密度试验RSD=0.5%(n=6);定量限为0.2495μg/ml;耐用性试验RSD=7.3%(n=5)结论:《中国药典》2010年版二部阿莫西林高分子聚合物测定方法重现性良好、准确可靠。Objective:to verify the methodfor the determination of amoxicillin capsule polymer in the second part of Chinese pharmacopoeia(2010 edition).Methods:the molecular exclusion method was used in high performance liquid chromatography,and the injection volume was 100μl Results:high polymer detection precision test RSD=0.5%(n=6);the limit of quantification was 0.2495 g/ml;the durability test of RSD=7.3%(n=5).Conclusion:the methodfor the determination of amoxicillin capsule polymer in the second part of Chinese pharmacopoeia(2010 edition)is accurate and reliable.

关 键 词：青霉素类药物 聚合物 分子排阻色谱法 

分 类 号：R[医药卫生]