HPLC法测定阿莫西林颗粒剂的含量及有关物质  

Quality control of amoxicillin granules by HPLC

作　　者：洪建文[1] 李趣嫦[1] 王彦蝶[2] 

机构地区：[1]广东省药品检验所,广东广州510180 [2]广东药学院

出　　处：《广东药学院学报》2009年第1期42-45,共4页Academic Journal of Guangdong College of Pharmacy

摘　　要：目的建立阿莫西林颗粒剂中阿莫西林的含量测定及有关物质检查的方法。方法以十八烷基硅烷键合硅胶为填充剂,以0.05 mol/L磷酸二氢钾溶液（pH值5.0）-乙腈（体积比97.5∶2.5）为含量测定的流动相;以0.05 mol/L磷酸二氢钾溶液（pH值5.0）-乙腈（体积比99∶1）为流动相A,0.05mol/L磷酸二氢钾溶液（pH5.0）-乙腈（体积比80∶20）为流动相B,梯度洗脱检查有关物质,检测波长230 nm,柱温30℃,流速1.0 mL/min。结果阿莫西林分别在0.1-1 mg/mL（r=0.999 9,n=7）与0.049-0.0012mg/mL（r=0.999 8,n=5）范围内与峰面积线性关系良好,低、中、高3个浓度的回收率分别为100.2%、99.8%和100.0%（RSD=0.2%,n=9）。阿莫西林有关物质检查的检测限为2 ng,且主成分与有关杂质均能有效分离。结论本文建立的含量测定方法快速、准确、重现性好,有关物质检查方法专属、灵敏,可用于阿莫西林颗粒剂的质量控制。Objective To establish an HPLC method for analyzing the contents of amoxicillin and other related substances in amoxicillin granules. Methods Amoxicillin contents were analyzed on a C,s column using 0.05 mol/L KH2PO4-acetonitrile （97.5： 2.5） as mobile phase under the flow rate of 1.0 mL/min. Impurities were analyzed by using gradient elution. Mobile phase A was 0.05 mol/L KH2PO4-acetonitrile （99：1 ） and mobile phase B 0.05 mol/L KH2PO4-acetonitrile （80： 20）. The detection wavelength was 230 nm and the column temperature 30 ℃. Results Amoxicillin had good linearity in the range of 0.1 - 1 mg/ mL（r = 0. 999 9, n = 7） and 0. 049 - 0. 0012 mg/mL（ r = 0. 999 8, n = 5 ）. The recovery of Amoxicillin was 100.2% ,99.8% and 100.0% respectively （ RSD = 0. 2%, n = 9 ）. The detection limit of related substance was 2 ng, and the principal components can be well separated from the impurities. Conclusion This method is quick, accurate and reproducible, which could be used for the quality control of amoxicillin granules.

关 键 词：阿莫西林颗粒剂 含量测定 有关物质 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]