摘要
目的 建立电位滴定法测定环丝氨酸原料药的含量。方法 采用Mettler T5全自动电位滴定仪和DGi111-SC复合玻璃p H电极,以30 ml水和20 ml盐酸溶液(0.01 mol/L)为溶剂,用氢氧化钠滴定液(0.1 mol/L)进行电位滴定。同时与《国际药典》收载的人工滴定法比较。结果 环丝氨酸在0.020 58~0.2512 g内线性关系良好(r=1.0000),平均回收率为99.59%,重复性RSD为0.3%,含量测定结果与《国际药典》方法无显著性差异。结论 本方法操作简便,测定快速,结果准确,可用于环丝氨酸的含量测定,并为环丝氨酸的质量标准提供参考。
Objective To establish a potentiometric titration method for the determination of cycloserine API.Methods Mettler T5 Excellence Titrator and DGi111-SC combined glass pH electrode were used,30 ml water and 20 ml hydrochloric acid solution(0.01 mol/L)were used as solvents,and sodium hydroxide titrant(0.1 mol/L)was used for potentiometric titration.And it was compared with the manual titration method included in the International Pharmacopoeia.Results The linear relationship of cycloserine was good within the range of 0.02058 to 0.2512 g(r=1.0000),with an average recovery rate of 99.59%and a repeatability RSD of 0.3%.There was no significant difference between the content determination results and the methods in the International Pharmacopoeia.Conclusion This method can be used for the determination of cycloserine content with simplified operation,rapid determination and accurate results.It also provides a reference for the specification of cycloserine.
作者
刘静兰
LIU Jinglan(Xiamen Institute for Food and Drug Quality Control,Fujian,Xiamen 361012,China)
出处
《中国医药科学》
2023年第17期82-85,共4页
China Medicine And Pharmacy
关键词
环丝氨酸
电位滴定
含量测定
氢氧化钠滴定液
Cycloserine
Potentiometric titration
Content determination
Sodium hydroxide titrant
