克拉维酸钾阿莫西林分散片的质量控制研究

Determination of potassium clavulanate and amoxicillin in its dispersible tablets

目的 :研究克拉维酸钾阿莫西林 (CVAK AMPC)分散片质量控制方法。方法 :采用HPLC测定分散片中克拉维酸钾 (CVA)和阿莫西林 (AMPC)的含量 ,并对崩解时限、分散均匀度、水分等进行控制。结果 :CVA和AMPC的平均回收率分别为 (10 0 .4± 0 .83) %和 (99.7± 0 .82 ) %。AMPC和CVA的日内和日间RSD分别小于2 .1% ,2 .7%和 2 .3% ,3.0 %。CVA和AMPC标准曲线相关性良好 (r=0 .9999)。结论 :制订的该分散片的质量控制标准 ,能够全面反映该制剂的质量 ,方法简便、切实可行。

Objective::To determine potassium clavulanate and amoxicillin in its dispersible tablets.Methods:The contents of potassium clavulanate and amoxicillin were determined by HPLC,at the same time the disintegration,uniformity of dispersion,water content of the tablets were also analyzed.Results:The mean recovery for potassium clavulanate and amoxicillin was (100.4±0.83)%and (99.7±0.82)% respectively.The intra day and inter day precision for potassium clavulanate as well as amoxicillin were 2.3% and 3.0% as well as 2.1% and 2.7% respectively.Conclusion:A convenient,selective,and reproducible method for determination of potassium clavulanate and amoxicillin is established.