盐酸伐地那非片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号2.0对照品来源自制对照品使用方法直接使用
对照品含量(%)90.50对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.307933677940287933857941657944057938700.06
212.257946647942047944340.05
单位质量响应值RSD%判断
64542.2864851.760.34数据可信
供试品溶液-24062601YD1批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1320816-32081637.58644.4912.4637.5944.4912.46
2446228-44622852.27952.28
3356495-35649541.76641.77
4392118-39211845.94045.94
5417399-41739948.90248.90
6345359-34535940.46240.46
10min1372633-37263343.65750.6011.0143.7250.6711.01
2499291-49929158.49658.58
3411537-41153748.21548.28
4441477-44147751.72351.80
5470230-47023055.09155.17
6396239-39623946.42346.49
15min1407141-40714147.70054.8510.1447.8455.0110.15
2535789-53578962.77262.96
3455125-45512553.32253.47
4475066-47506655.65855.82
5504993-50499359.16459.34
6430941-43094150.48850.63
20min1437151-43715151.21658.319.4451.4358.569.45
2560899-56089965.71466.00
3492988-49298857.75858.00
4503565-50356558.99759.25
5536483-53648362.85363.13
6455122-45512253.32153.55
30min1484157-48415756.72363.638.4757.0263.988.48
2606378-60637871.04271.44
3548325-54832564.24164.58
4544301-54430163.76964.12
5576556-57655667.54867.92
6498931-49893158.45458.77
45min1525474-52547461.56468.907.6461.9669.367.66
2642372-64237275.25975.78
3607788-60778871.20771.65
4586955-58695568.76769.23
5620252-62025272.66873.16
6545710-54571063.93464.35
60min1561228-56122865.75272.506.7366.2573.076.75
2667627-66762778.21878.86
3637920-63792074.73875.30
4616777-61677772.26072.84
5650471-65047176.20876.82
6578887-57888767.82168.34
90min1604955-60495570.87577.266.1671.4877.956.18
2706993-70699382.83083.60
3673736-67373678.93479.62
4647993-64799375.91876.61
5697919-69791981.76782.50
6625083-62508373.23473.87
120min1629791-62979173.78579.956.2674.5180.776.28
2729163-72916385.42786.34
3692349-69234981.11481.93
4663701-66370177.75878.58
5732206-73220685.78486.66
6647293-64729375.83676.59
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1686570-68657080.43784.804.3281.2985.754.36
2756884-75688488.67589.73
3734640-73464086.06987.02
4706889-70688982.81883.77
5760070-76007089.04890.07
6697619-69761981.73282.62
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