注射用亚锡亚甲基二膦酸盐冻干品中磷含量的快速测定

Quickly Determination of Phosphate Amount in Methylenediphosphonate and Stannous Chloride for Injection Kit

摘要: 建立了一种简便、快速的测定注射用亚锡亚甲基二膦酸盐冻干品中磷含量的分析方法，与中国药典2005版收录的方法比较，不需要通入硫化氢气体、离心、高温灼烧等步骤，简化了操作程序，缩短了分析时间，有利于生产中的质量控制。本方法的回收率为98.6%~101.3%，相对标准偏差 0.2%，与中国药典方法进行比较验证，结果较为满意。

Abstract: A quickly, simply method was applied to analyze phosphate amount in methylenediphosphonate and stannous chloride for injection kit. Without using H2S gas,centrifuge and high temperature cauterzation procedures, it’s simple and rapid comparing to China pharmacopoeia 2005. The accurate is as good as China pharmacopoeia’s method. The range of the recovery is 98.6%~101.3%，and relative standard diversion(RSD) is less than 0.2%.