坎地沙坦酯氢氯噻嗪片项目信息
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100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.31 4620344622584621514619934619984620870.03
212.334638394637484637940.02
单位质量响应值RSD%判断
37537.5337615.090.15数据可信
供试品溶液-2批-氢氯噻嗪-含0.35%吐温20的pH6.8磷酸盐溶液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1195332-19533237.31543.5922.7437.3243.6022.73
2203251-20325138.82838.83
3184342-18434235.21635.22
4200099-20009938.22638.23
5310674-31067459.35059.35
6275460-27546052.62352.62
10min1361878-36187869.13271.247.2769.1971.327.29
2346840-34684066.25966.32
3346384-34638466.17266.23
4371580-37158070.98571.05
5410406-41040678.40278.50
6400534-40053476.51676.60
15min1427190-42719081.60881.913.2381.7982.113.25
2417387-41738779.73679.91
3408969-40896978.12878.30
4433242-43324282.76582.95
5441004-44100484.24784.48
6444969-44496985.00585.22
20min1453893-45389386.71086.641.9487.0286.971.96
2444599-44459984.93485.24
3443008-44300884.63084.93
4455172-45517286.95487.27
5457835-45783587.46387.83
6466695-46669589.15589.51
30min1474898-47489890.72290.881.2191.1891.361.23
2469203-46920389.63490.08
3469122-46912289.61990.06
4481072-48107291.90292.37
5477813-47781391.27991.80
6482332-48233292.14392.65
45min1495073-49507394.57794.820.4095.1995.450.43
2494052-49405294.38194.98
3494850-49485094.53495.12
4497124-49712494.96895.59
5498894-49889495.30695.97
6498168-49816895.16895.83
60min1510372-51037297.49997.920.3798.2798.700.39
2510585-51058597.54098.30
3512198-51219897.84898.60
4513219-51321998.04398.82
5515053-51505398.39399.22
6513968-51396898.18699.00
极限1533222-533222101.864102.480.79102.79103.430.76
2538273-538273102.829103.75
3540865-540865103.324104.23
4540957-540957103.342104.28
5530815-530815101.404102.40
6534643-534643102.136103.12
坎地沙坦酯氢氯噻嗪片项目信息
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100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.133179263179603151843175533181093173460.39
216.093193153192913193030.01
单位质量响应值RSD%判断
19674.2719844.810.62数据可信
供试品溶液-2批-坎地沙坦酯-含0.35%吐温20的pH6.8磷酸盐溶液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min179919-7991922.70626.1923.0622.7126.1923.06
281683-8168323.20723.21
373957-7395721.01221.01
480228-8022822.79322.79
5126372-12637235.90335.90
6110997-11099731.53531.54
10min1189147-18914753.73857.099.3853.7857.149.39
2187076-18707653.15053.19
3181709-18170951.62551.66
4199851-19985156.77956.82
5226213-22621364.26964.33
6221732-22173262.99663.05
15min1257278-25727873.09574.083.9973.2274.224.00
2252918-25291871.85671.98
3246857-24685770.13470.26
4262729-26272974.64474.78
5272181-27218177.32977.50
6272482-27248277.41477.57
20min1293984-29398483.52383.612.2683.7783.872.27
2289097-28909782.13582.38
3285957-28595781.24381.48
4294428-29442883.65083.91
5297279-29727984.46084.76
6304966-30496686.64386.93
30min1323357-32335791.86891.761.0592.2692.161.06
2320756-32075691.13091.51
3319408-31940890.74791.12
4327826-32782693.13893.53
5320408-32040891.03191.47
6326068-32606892.63993.07
45min1335351-33535195.27695.330.5295.8295.880.50
2336811-33681195.69196.23
3335653-33565395.36295.89
4336675-33667595.65296.20
5332225-33222594.38894.98
6336477-33647795.59696.18
60min1337471-33747195.87896.070.2896.5896.780.26
2339268-33926896.38997.08
3338973-33897396.30596.99
4338128-33812896.06596.78
5336813-33681395.69196.44
6338218-33821896.09196.84
极限1338212-33821296.08996.450.3796.9597.330.35
2340720-34072096.80197.66
3340774-34077496.81797.66
4340296-34029696.68197.55
5338819-33881996.26197.17
6338128-33812896.06596.97
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