枸橼酸西地那非片项目信息
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
420012-202204
对照品来源
中检院
对照品使用方法
直接使用
对照品含量(%)
98.8
对照品水分(%)
0
对照品稀释倍数
250
标示量(mg)
50
供试品稀释倍数
1
系数
0.7118
对照品溶液
序号
称样量(mg)
A
1
A
2
A
3
A
4
A
5
A
平均
RSD%
1
17.60
465850
465731
465647
465463
465684
465675
0.04
2
17.63
463586
464229
463908
0.10
单位质量响应值
RSD%
判断
26458.81
26313.56
0.39
数据可信
供试品溶液-50124002批-pH6.8
时间
(分钟)
样品
A
1
A
2
A
平均
溶出量(%)
平均(%)
RSD%
累计溶
出量(%)
平均(%)
RSD%
5min
1
384434
-
384434
73.773
72.98
2.00
73.77
72.98
2.00
2
378862
-
378862
72.703
72.70
3
386458
-
386458
74.161
74.16
4
366817
-
366817
70.392
70.39
5
378306
-
378306
72.597
72.60
6
387043
-
387043
74.273
74.27
10min
1
391091
-
391091
75.050
74.51
1.14
75.17
74.63
1.14
2
382532
-
382532
73.408
73.53
3
391772
-
391772
75.181
75.30
4
383323
-
383323
73.560
73.68
5
388261
-
388261
74.507
74.63
6
392700
-
392700
75.359
75.48
15min
1
387137
-
387137
74.291
74.06
0.96
74.54
74.30
0.96
2
383678
-
383678
73.628
73.87
3
388975
-
388975
74.644
74.89
4
379872
-
379872
72.897
73.14
5
386092
-
386092
74.091
74.34
6
389782
-
389782
74.799
75.05
20min
1
386861
-
386861
74.238
73.27
2.01
74.61
73.64
2.00
2
381091
-
381091
73.131
73.50
3
386495
-
386495
74.168
74.54
4
379089
-
379089
72.747
73.11
5
368197
-
368197
70.657
71.03
6
389090
-
389090
74.666
75.04
30min
1
383568
-
383568
73.607
73.09
1.03
74.10
73.58
1.03
2
376616
-
376616
72.272
72.76
3
382591
-
382591
73.419
73.92
4
375960
-
375960
72.147
72.63
5
380668
-
380668
73.050
73.54
6
385730
-
385730
74.021
74.52
45min
1
380157
-
380157
72.952
72.30
1.19
73.57
72.91
1.19
2
371714
-
371714
71.332
71.94
3
379296
-
379296
72.787
73.41
4
371019
-
371019
71.198
71.80
5
376763
-
376763
72.301
72.91
6
381544
-
381544
73.218
73.84
极限
1
373645
-
373645
71.702
71.00
0.90
72.44
71.74
0.90
2
366843
-
366843
70.397
71.12
3
370063
-
370063
71.015
71.76
4
365920
-
365920
70.220
70.94
5
369770
-
369770
70.959
71.69
6
373782
-
373782
71.729
72.47
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图1 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转<br>溶剂 图2 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转<br>对照品溶液-1-1 图3 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转<br>对照品溶液-1-2 图4 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转<br>对照品溶液-1-3 图5 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转<br>对照品溶液-1-4 图6 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转<br>对照品溶液-1-5 图7 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-5min-片1<br>供试品溶液-1 图8 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-5min-片2<br>供试品溶液-1 图9 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-5min-片3<br>供试品溶液-1 图10 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-5min-片4<br>供试品溶液-1 图11 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-5min-片5<br>供试品溶液-1 图12 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-5min-片6<br>供试品溶液-1 图13 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-10min-片1<br>供试品溶液-1 图14 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-10min-片2<br>供试品溶液-1 图15 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-10min-片3<br>供试品溶液-1 图16 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-10min-片4<br>供试品溶液-1 图17 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-10min-片5<br>供试品溶液-1 图18 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-10min-片6<br>供试品溶液-1 图19 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-15min-片1<br>供试品溶液-1 图20 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-15min-片2<br>供试品溶液-1 图21 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-15min-片3<br>供试品溶液-1 图22 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-15min-片4<br>供试品溶液-1 图23 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-15min-片5<br>供试品溶液-1 图24 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-15min-片6<br>供试品溶液-1 图25 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-20min-片1<br>供试品溶液-1 图26 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-20min-片2<br>供试品溶液-1 图27 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-20min-片3<br>供试品溶液-1 图28 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-20min-片4<br>供试品溶液-1 图29 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-20min-片5<br>供试品溶液-1 图30 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-20min-片6<br>供试品溶液-1 图31 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-30min-片1<br>供试品溶液-1 图32 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-30min-片2<br>供试品溶液-1 图33 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-30min-片3<br>供试品溶液-1 图34 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-30min-片4<br>供试品溶液-1 图35 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-30min-片5<br>供试品溶液-1 图36 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-30min-片6<br>供试品溶液-1 图37 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-45min-片1<br>供试品溶液-1 图38 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-45min-片2<br>供试品溶液-1 图39 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-45min-片3<br>供试品溶液-1 图40 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-45min-片4<br>供试品溶液-1 图41 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-45min-片5<br>供试品溶液-1 图42 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-45min-片6<br>供试品溶液-1 图43 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-极限转速-片1<br>供试品溶液-1 图44 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-极限转速-片2<br>供试品溶液-1 图45 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-极限转速-片3<br>供试品溶液-1 图46 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-极限转速-片4<br>供试品溶液-1 图47 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-极限转速-片5<br>供试品溶液-1 图48 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转-极限转速-片6<br>供试品溶液-1 图49 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转<br>对照品溶液-2-1 图50 枸橼酸西地那非片溶出曲线测定HPLC图谱<br>自制品-50124002批(50mg规格)-pH6.8介质-篮法-100转<br>对照品溶液-2-2
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