HPLC法测定地塞米松磷酸钠注射液含量的不确定度分析.PDFVIP

药学与临床研究 2008年 8月 Pha rmaceutci a l and C linica l Research 2008, 16 ( 4) # 药学研究# HPLC 朱静毅, 房克慧 江苏省扬州药品检验所, 扬州225009 : 建立H PLC 法测定地塞米松磷酸钠注射液含量的 确定度分析方法: 通过建立 HPLC 含量测定法的数学模型, 找出影响 确定度的因素并对各 个 确定度分量进行评估: 计算各变量的 确 定度, 由此计算合成 确定度, 最终给出测定结果的扩展 确定度: 测量 确定度可用于对地塞米松磷酸 钠含量测定结果的评价, 测量 确定度的评定对于药品检验具有重要意义 地塞米松磷酸钠; 含量; HPLC法; 确定度 R927. 1 A 1673-7806( 2008) 04-258-04 Uncertainty analysis assay for dexamethasone sodium phosphate injection with HPLC ZHU Jin -y i, FANG Ke-hu i Yangzhou Institution f or Drug Control of Jiang su Prov ince, Yangzhou 225009, China Abstract O bjective: To estab lish an uncertainty analysis method for assay of dexamethasone sodium phosphate injection w ith HPLC. M e thods: A mathematicmodel was established w ith HPLC to identify the influence factors mi pactin uncertainty and each component of uncertainty w as also evaluated. Re- su lts: Each component of uncertaintyw as calculated by analyzin the various variab le parameters in the procedure, the comb ined uncertainty and expanded uncertaintyw ere finally obtained. Conc lusoi n: The mathematic model of uncertainty w as estab lished in th is paper is applicab le to evaluate the accuracy of assay of dexamethasone sodium phosphate injection. The establishment of themethodolo y for the evalua- tion ofmeasurement uncertainty is mi portant in dru control. Keywords Dexamethasone sodium phosphate; Content; HPLC; M easurement uncertainty / 6HPLC , 0, , , , , HPLC , ,