阿莫西林/克拉维酸钾原料及制剂中有关物质测定方法的比较  

Comparative studies on determination of related substances of amoxicillin-potassium clavulanate and its preparations

作　　者：周晓溪[1] 顾立素[1] 逄涣欢[1] 胡昌勤[1] 冯芳[2] 

机构地区：[1]中国药品生物制品检定所 [2]中国药科大学,南京210009

出　　处：《中国抗生素杂志》2005年第12期737-740,743,共5页Chinese Journal of Antibiotics

摘　　要：目的建立两种HPLC线性梯度洗脱测定阿莫西林/克拉维酸钾有关物质的方法,并对其进行比较。方法两种方法均采用C18柱,流速1.0ml/min,所用流动相为磷酸盐缓冲液∶乙腈色谱系统。方法一中流动相A为0.05mol/L磷酸盐缓冲液(pH5.0)∶乙腈(99∶1),流动相B为0.05mol/L磷酸盐缓冲液(pH5.0)∶乙腈(80∶20);方法二中流动相A为0.01mol/L磷酸盐缓冲液(pH6.0),流动相B为0.01mol/L磷酸盐缓冲液(pH6.0)∶乙腈(20∶80)。两种方法的梯度变化不同。方法一和方法二的检测波长分别为254和215nm。结果两种方法的线性范围、检测限及测定结果基本一致。结论两种方法准确,专属性强,灵敏度高,适用于阿莫西林/克拉维酸钾中有关物质测定,且方法一的稳定性优于方法二。Objective Two HPLC methods with linear gradient elution for determination of the related substances of amoxicillin-potassium clavulanate were established and compared. Methods In the two methods, the flow rates were both 1.0 ml/min and the separation was carried out using C18 column with mobile phase of phosphate buffer-acetonitrile. In the first method, the mobile phase A was 0.05 mol/L phosphate buffer （pH 5.0） ： acetonitrile （99 ： 1） and the mobile phase B was 0. 05 mol/L phosphate buffer （pH5. 0） ： acetonitrile （80 ： 20）. In the second method, the mobile phase A was 0. 01 mol/L phosphate buffer （pH 6.0） and the mobile phase B was 0.01 mol/L phosphate buffer （pH 6.0） ： acetonitrile （20 ： 80）. The linear gradient elution is different in the two methods. The detection wavelengths for the two methods were 254nm and 215nm, respectively. Results There is no distinct difference between the two methods in the liner range, the detection limits and the contents of the related substances. Conclusion The two methods are accurate, sensitive and suitable for the study on the related substances of amoxicillin-potassium clavulanate. The reproducibility of the first method is better than the second one.

关 键 词：阿莫西林/克拉维酸钾 有关物质 HPLC 

分 类 号：R927.2[医药卫生—药学]