阿莫西林克拉维酸钾片溶出曲线检测方法的建立与验证

Establishment and Validation of the test method for amoxicillin and clavulanate potassium tablets dissolution profile

目的建立并验证一种测定阿莫西林克拉维酸钾片溶出曲线的方法。方法溶出方法:桨法,溶出介质:水,体积:900mL,转速75rpm·min^(-1),取样点:5、10、15、30、45分钟;检验方法:色谱柱为Welch ultimate AQ-C18(4.6×250mm,5μm),流动相为甲醇—磷酸盐缓冲液(7.8g·L^(-1)磷酸二氢钠溶液,调节pH值至(4.4±0.1))=5:95,检测器波长为220nm,进样体积为20μL。对该方法进行了专属性、准确度、精密度等项目验证,结果符合要求。结论该方法专属性好、灵敏度高、溶出范围内线性关系良好,精密度与准确度均符合要求,滤膜吸附低,能够满足仿制药研发过程中处方筛选的需要。

Objective To establish and validate a dissolution profile method for the amoxicillin and clavulanate potassium tablets.Methods Dissolution method:Paddle;Dissolution medium:Water;Volume:900 mL;Revolution speed:75 rpm·min^(-1);Sample point:5,10,15,30,45 minute.Analysis Method:Column:Welch ultimate AQ-C184.6×250 mm 5μm;Mobile phase:7.8 g·L^(-1) phosphate buffer solution(adjust pH to 4.4±0.1)-methanol=95:5;Detection wavelength:220 nm;Injection volume:20μL.The method was verified for its specificity,accuracy,precision and other items,and the results met the requirements.Conclusion The method has good specificity,high sensitivity,good linearity in the dissolution range.The low filter membrane adsorption,both precision and accuracy meet the requirements,which can meet the needs of prescription screening during generic drug development.