摘要
对《中国兽药典》中卡巴匹林钙的水分测定法进行了改进,从取样量、加入样品后的搅拌时间、二甲基甲酰胺与无水甲醇的比例、连续测定样品的份数、滴定杯中的溶剂使用量5个方面对现行标准方法进行了优化,解决了现行标准方法测定结果平行性差、无法真实反映产品质量等问题。通过与干燥失重法和气相色谱法的比较,验证了改进后方法的可靠性。还对现行标准方法问题产生的原因、实验的注意事项等进行了研究。
The method from Chinese Veterinary Pharmacopoeia(CVP)for the determination of water in Carbasalate Calcium was improved.The new method was optimized by sample weighting amount,mixing time after inputting sample,the ratio of dimethylformamide to methanol,pieces of sample and quantity of solvent in titration vessel.The problem of poor data repeatability was overcomed.The reliability of new method was verified by comparison with loss on drying and gas chromatography.The cause of the problem and experimental considerations were discussed too.
作者
于晓辉
王雷
杨星
马秋冉
YU Xiao-hui;WANG Lei;YANG Xing;MA Qiu-ran(China Institute of Veterinary Drug Control,Beijing 100081,China)
出处
《中国兽药杂志》
2023年第12期56-61,共6页
Chinese Journal of Veterinary Drug
关键词
卡巴匹林钙
费休氏法
数据平行性
质量控制
Carbasalate Calcium
Karl Fischer titration
data repeatability
quality control