摘要
目的:建立维地西林涂剂的制备工艺及质量控制方法。方法:以研磨法制备维地西林涂剂,采用高效液相色谱法测定含量。色谱柱为C18柱,流动相0.05 mol/L磷酸二氢钾溶液-乙腈(97.5∶2.5),流速1 mL/min,检测波长254 nm。结果:所制维地西林涂剂为黄色混悬液,其主药阿莫西林在0.05～0.45 mg/mL范围内与峰面积呈良好的线性关系,线性方程为A=44.5799C+0.188(r=0.999 9),平均回收率为98.7%,RSD为1.18%。结论:研磨法制备维地西林涂剂工艺可行,高效液相色谱法用于维地西林涂剂中阿莫西林含量的测定,方法简便,结果重现性好,适用于该制剂的质量控制。
Objective： To prepare verdicyclime paint and establish the preparation and quality control procedures. Methods： erdieyline paint with grinding was prepared and the high performance liquid chromatography was chose to determine amoxicillin content, with C is column and potassium dihydrogen phosphate-aeetonitrile （97.5 ： 2.5 ） of 0.05 mol/L as the mobile phase. The flow rate was 1 mL/min and detection wavelength was 254 nm. Results： The verdieyline paint was yellow suspension, amoxicillin showed a good linear relation in a range of 0. 05 -0.45 mg/mL, the curve equation was A =44. 5799C＋0. 188, r = 0. 9999, the average recovery was 98.7% and RSD was 1.18%. Conclusions： Preparation of verdicyclime with grinding is a feasible method and the quality control is easy, simple and reproducible to apply the high performance liquid chromatography in the determination of amoxicillin content in verdicyline.
出处
《儿科药学杂志》
CAS
2012年第11期37-39,共3页
Journal of Pediatric Pharmacy
关键词
维地西林涂剂
质量控制
阿莫西林
高效液相色谱法
Verdicyline paint
Quality control
Amoxicillin
High performance liquid chromatography
