兽用氨苄西林可溶性粉及氨苄西林钠可溶性粉含量测定方法改进OA
Improvement of the content determination method for veterinary ampicillin soluble powder and ampicillin sodium soluble powder
研究旨在建立科学、有效的氨苄西林可溶性粉及氨苄西林钠可溶性粉含量测定检测方法.采用高效液相色谱(high-performance liquid chromatography,HPLC)梯度洗脱方法,依据注射用氨苄西林质量标准,流动相A为12%醋酸溶液-0.2 mol/L磷酸二氢钾溶液-乙腈-水(0.5∶50.0∶50.0∶900.0);流动相B为12%醋酸溶液-0.2 mol/L磷酸二氢钾溶液-乙腈-水(0.5∶50.0∶400.0∶550.0),对最大吸收波长以及不同色谱柱、柱温、流速等条件进行探索.结果显示:该方法具有良好的精密度、稳定性、重复性,相对标准偏差(RSD值)≤0.6%,线性相关系数(R2)为1,回收率为97.52%~101.15%.研究表明,试验建立的方法能够实现氨苄西林与头孢拉定的有效分离,统一了氨苄西林及其制剂的含量测定方法.
The research aims to establish a scientific and effective method for determining the content of ampicillin soluble powder and ampicillin sodium soluble powder.The high-performance liquid chromatography(HPLC)gradient elution method was adopted,based on the quality standard for injectable ampicillin.The mobile phase A was 12%acetic acid solution-0.2 mol/L potassium dihydrogen phosphate solution-acetonitrile-water(0.5:50.0:50.0:900.0);the mobile phase B was 12%acetic acid solution-0.2 mol/L potassium dihydrogen phosphate solution-acetonitrile-water(0.5:50.0:400.0:550.0).The maximum absorption wavelength and different chromatographic columns,column temperature,flow rate,etc.were explored.The results showed that this method has good precision,stability,and repeatability.The relative standard deviation(RSD value)is≤0.6%,the linear correlation coefficient(R2)is 1,and the recovery rate is 97.52%to 101.15%.The study indicates that the established method in the experiment can achieve effective separation of ampicillin and cefradine,and standardizes the content determination methods for ampicillin and its preparations.
高婷;李月;杜继红;巩浩;李浛;周艳飞;刘思钰;王亚芳
北京市兽药饲料监测中心,北京 102200北京市兽药饲料监测中心,北京 102200北京市兽药饲料监测中心,北京 102200北京市兽药饲料监测中心,北京 102200北京市兽药饲料监测中心,北京 102200北京市兽药饲料监测中心,北京 102200北京市兽药饲料监测中心,北京 102200北京市兽药饲料监测中心,北京 102200
农业科技
氨苄西林高效液相色谱氨苄西林钠
AmpicillinHigh-performance liquid chromatographyAmpicillin sodium
《现代畜牧兽医》 2026 (3)
21-24,4
评论