高效液相色谱法测定注射用阿莫西林钠克拉维酸钾的有关物质

Determination of related substances in amoxicillin sodium and clavulanate potassium injection by HPLC

目的 :采用高效液相色谱法测定注射用阿莫西林钠克拉维酸钾的有关物质。方法 :Dikma ODS C1 8色谱柱(2 5 0 mm× 4 .6 mm,5μm) ,磷酸盐缓冲液 (磷酸二氢钠 7.8g,加水 90 0 ml溶解 ,用磷酸调节 p H值至 (4 .4± 0 .1) ,加水至10 0 0 ml) -甲醇 (95∶ 5 )为流动相 ,室温 ,流速 0 .8ml/min,检测波长 2 2 0 nm,自身对照外标法。结果 :阿莫西林在 0 .18～3μg、克拉维酸在 0 .0 36～ 0 .6 μg范围内呈良好的线性关系 ,r均为 0 .9999,精密度试验 RSD分别为 0 .12 %和 0 .13% ,最低检出量分别为 0 .0 6 μg和 0 .0 12 μg。结论 :本方法简便、快速、准确 ,可有效控制质量。

Object: To establish an HPLC method for the determination of related substances in amoxicillin sodium and clavulanate potassium injection. Methods: A Dikma ODS C 18 column (250 mm×4.6 mm,5 μm) was used with phosphate buffer (dissolving sodium dihydrogen phosphate 7.8 g in 900 ml of water, adjusting to pH (4.4±0.1) by phosphoric acid and adding sufficient water to 1 000 ml)-methanol (95∶5) as the mobile phase. The flow rate was 0.8 ml/min and the detection was performed at UV 220 nm and at room temperature.The external standard method was adopted. Results: The calibration curves were linear in the concentration range of 0.18～3 μg for amoxicillin(r=0.999 9) and 0.036～0.6 μg for clavulanate(r=0.999 9). The lower limits of quantitation were 0.06 μg and 0.012 μg and the RSD of the precision were 0.12% and 0.13%, respectively. Conclusion: The method is simple, rapid and accurate.