高效液相色谱法测定阿莫西林克拉维酸钾分散片(4∶1)的含量均匀度

Determination of content uniformity of amoxicillin and Clavulanate Potassium Dispersible tablets by HPLC

目的建立阿莫西林克拉维酸钾分散片含量均匀度的测定方法。方法以0.05mol.L-1磷酸二氢钠溶液∶甲醇(95∶5)为流动相,流速:1.0mol.min-1,检测波长:220nm,用义效液相色谱法测定含量。结果阿莫西林质量浓度在78.92～710.30μg.mL-1、克拉维酸质量浓度在22.28～200.54μg.mL-1范围内与峰面积线性关系良好,平均回收率分别为98.4%和98.4%,RSD分别为1.0%和2.0%。结论所用方法简便快捷,能准确地测定产品的含量均匀度,可用于阿莫西林克拉维酸钾分散片的质量控制。

OBJECTIVE To establish a method to determine the content uniformity of Amoxicillin and Clavulanate Potassium Dispersible Tablets.METHODS The HPLC method was used.0.05mol·L-1 sodium dihydrogen phosphate-methanol（95∶5）was used as the mobile phase with flow rate of 1.0mL·min-1,and the detection wavelength was 220nm.RESULTS There was a good linearity of amoxicillin within the range of 78.92～710.30μg·mL-1 and clavulanate within the range of 22.27～200.46μg·mL-1.The average recovery rate was 98.4%（RSD=1.0%） and 98.4%（RSD=2.0%） respectively.CONCLUSION This method is convenient,simple,quick and reproducible,which can quantitatively determine the content uniformity of Amoxicillin and Clavulanate Potassium Dispersible Tablets and is suitable for the quality control of Amoxicillin and Clavulanate Potassium Dispersible Tablets.