摘要
目的:建立氨苯蝶啶片溶出度测定方法。方法:采用转篮法,以盐酸溶液(9→1000)为溶剂,转速为100r.min^(-1),45min时取样,以紫外分光光度法测定,检测波长为357nm。结果:氨苯蝶啶在1.0-10.0μg·mL^(-1)的浓度范围内,线性关系良好。线性方程为:A=8.39×10^(-2)C+2.1×10^(-3)(r=1.000);3个厂家8批样品测定结果显示,仅有2批样品在45min 的溶出量不低于标示量的75%。结论:氨苯蝶啶在水中不溶,增加其片剂溶出度检查项极为必要。本方法操作简便,结果准确,为完善氨苯蝶啶片的质量标准提供有效手段。
Objective:The UV method was described for determination of the dissolution of triamterene tablets. Method:The apparatus was used with hydrochloric acid(9→1000)as dissolution medium at a rotate speed of at 100 r·min^(-1).According to the UV method,the absorbance of triamterene which was dissolved from its tablets in 45 mi- nutes was determined at the wavelength of maximum absorbanee at about 357 nm.Results:The linear range of tri- amterene was 1.0-10.0μg·mL^(-1),A=8.39×10^(-2)C+2.1×10^(-3)(r=1.000).The dissolutions of eight sam- ples produced by three different factories were tested,only two samples meeted the tolerances(not less than 75% of the labeled amount of triamterene dissolved in 45 minutes).Conclusion:Because triamterene is not dissolved in wa- ter.It is necessary to set up the method of dissolution of triamterene tablets.The method is rapid,convenient,accu- rate and reliable.It can be used as a reliable method of quality control for triamterene tablets.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2005年第4期473-475,共3页
Chinese Journal of Pharmaceutical Analysis
