培哚普利氨氯地平片项目信息
介质体积(ml)1000取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.442170321592217512174321820217220.39
210.432160321757216800.51
单位质量响应值RSD%判断
2080.652078.620.07数据可信
供试品溶液-培哚普利-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2022081601121591214482152098.1098.861.3897.43%～100.29%
221504214032145497.80
321714217252172099.01
421354213372134697.31
5220032207822040100.47
6220842199022037100.46
2022071701121740218772180899.4199.141.5697.52%～100.75%
221272213092129097.05
3222132211122162101.03
421704216802169298.88
521571213662146897.86
6221032202922066100.59
2022081801121917219062191299.89100.361.5398.75%～101.97%
2221752232222248101.42
3220332206622050100.51
421412214802144697.76
5225062236422435102.27
6220952190822002100.30
培哚普利氨氯地平片项目信息
介质体积(ml)1000取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.981640011642101641161639061641151640700.08
213.991632771636671634720.17
单位质量响应值RSD%判断
11736.0511684.920.31数据可信
供试品溶液-氨氯地平-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2022081601116100316084916092698.98100.381.6798.62%～102.13%
216116316157616137099.25
316227516225916226799.81
416110116147816129099.21
5166662166588166625102.49
6166675166639166657102.51
2022071701116228716203816216299.74100.101.3598.68%～101.51%
215980716012815996898.39
3165573165442165508101.80
416248316229216238899.88
516124616124916124899.18
6165219165118165168101.59
20220818011162672162589162630100.03100.840.9899.82%～101.87%
2166485166676166580102.46
3163314163074163194100.38
416237916245316241699.90
5165065164937165001101.49
6164057163725163891100.81
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