原料药和片剂中泼尼松的高压液相色谱测定法
High pressure liquid chromatographic assay for prednisone in bulk drug substances and tablets.
作者信息
Graham R E, Biehl E R, Uribe M J
出版信息
J Assoc Off Anal Chem. 1983 Mar;66(2):264-72.
A high pressure liquid chromatographic (HPLC) method was developed for the assay of prednisone in bulk drug substances and tablets. The sample was dissolved in water-methanol and an aliquot was analyzed by using HPLC. The average recovery of prednisone added to a prednisone tablet composite was 99.5% with a coefficient of variation of 1.07%. Prednisone was determined in 46 tablets (1-50 mg prednisone/tablet) formulated by 22 manufacturers, using the HPLC method and the USP blue tetrazolium assay. The results show that the HPLC method is more specific and faster than the USP method.
建立了一种高压液相色谱（HPLC）法，用于原料药和片剂中泼尼松的含量测定。将样品溶于水 - 甲醇中，取一份溶液用HPLC进行分析。添加到泼尼松片剂混合物中的泼尼松平均回收率为99.5%，变异系数为1.07%。采用HPLC法和美国药典蓝四氮唑法对22家制造商生产的46种片剂（每片含1 - 50 mg泼尼松）中的泼尼松进行了测定。结果表明，HPLC法比美国药典方法更具特异性且速度更快。
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