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七位分析工作者用正相高效液相色谱法研究了片剂及原料药中氢化泼尼松的测定。所用高效液相色谱系统为硅胶柱,以甲醇—水—二氯甲烷—醋酸为流动相,分析了原料药、单方片剂及复方片剂,共16个样品,包括模拟配方、商品片剂、原包装片剂及原料药等。各分析工作者所得结果与作者一致,变异系数为1.34%(原料药)～2.14%(片剂)。本文建议用高效液相色谱法代替法定的 AOAC 及 USPXX 所用的四氮唑比色测定法。
Seven analysts analyzed the determination of prednisolone in tablets and APIs using normal-phase high performance liquid chromatography. The high performance liquid chromatography (HPLC) system was a silica gel column. The mobile phase was methanol - water - methylene chloride - acetic acid. The raw materials, the unilateral tablets and the compound tablets were analyzed. A total of 16 samples including simulated formula, Original packaging tablets and APIs. The results obtained by each analyst were consistent with those of the authors, with a coefficient of variation of 1.34% (APIs) to 2.14% (tablets). This paper suggests that HPLC should be used in place of the tetrazolium colorimetric assay used in the approved AOAC and USPXX.