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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7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%
112.054480454486294483204482314479624482370.06
211.934481574482214481890.02
单位质量响应值RSD%判断
37198.0937568.230.71数据可信
中间条件6月-供试品溶液-519819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%
5min1206166-20616639.58939.257.9639.5939.257.96
2194764-19476437.40037.40
3215662-21566241.41341.41
4179205-17920534.41234.41
5204791-20479139.32539.33
6225919-22591943.38343.38
10min1332396-33239663.82965.654.6063.8965.714.60
2323022-32302262.02962.09
3351477-35147767.49367.56
4330408-33040863.44763.50
5349661-34966167.14467.21
6364275-36427569.95170.02
15min1386256-38625674.17276.704.5474.3476.884.54
2379318-37931872.83973.01
3415712-41571279.82880.01
4383769-38376973.69473.86
5412766-41276679.26279.44
6418876-41887680.43580.62
20min1420912-42091280.82683.224.0281.1283.534.03
2414371-41437179.57079.86
3454126-45412687.20487.52
4418300-41830080.32580.61
5444720-44472085.39885.71
6447996-44799686.02786.35
30min1469727-46972790.20089.321.8090.6389.761.81
2456001-45600187.56487.98
3477874-47787491.76592.22
4456651-45665187.68988.11
5463125-46312588.93289.38
6467614-46761489.79590.26
45min1485797-48579793.28692.551.2493.8793.141.23
2477727-47772791.73692.30
3489879-48987994.07094.68
4484008-48400892.94393.51
5473239-47323990.87591.47
6481256-48125692.41493.03
60min1492226-49222694.52193.481.3795.2694.221.35
2484902-48490293.11493.83
3493072-49307294.68395.45
4491579-49157994.39695.12
5476468-47646891.49592.25
6482540-48254092.66193.43
极限1503983-50398396.77896.870.8697.6797.770.85
2506541-50654197.27098.14
3507546-50754697.46398.39
4506500-50650097.26298.14
5496051-49605195.25596.16
6506233-50623397.21098.13
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(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.061524801522441522801523121525111523650.08
216.061527181527971527580.04
单位质量响应值RSD%判断
9487.249511.710.19数据可信
中间条件6月-供试品溶液-519819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%
5min136496-3649621.56721.047.7621.5721.047.77
234366-3436620.30920.31
336958-3695821.84121.84
430822-3082218.21418.21
536116-3611621.34321.34
638896-3889622.98622.99
10min178882-7888246.61647.914.9446.6547.944.94
277452-7745245.77145.80
382531-8253148.77248.81
477221-7722145.63445.66
582812-8281248.93848.97
687564-8756451.74651.78
15min1109054-10905464.44666.584.7964.5666.704.79
2107403-10740363.47063.58
3117138-11713869.22369.34
4107025-10702563.24763.35
5116754-11675468.99669.11
6118664-11866470.12570.25
20min1129180-12918076.34079.074.5376.5679.304.53
2128895-12889576.17176.39
3140453-14045383.00183.23
4127052-12705275.08275.29
5137664-13766481.35381.59
6139550-13955082.46882.71
30min1153749-15374990.85991.042.5891.2191.402.58
2151306-15130689.41589.76
3159978-15997894.54094.91
4148623-14862387.82988.17
5154101-15410191.06791.43
6156537-15653792.50692.89
45min1162757-16275796.18296.011.5596.6896.521.55
2161864-16186495.65496.15
3166779-16677998.55999.09
4161177-16117795.24895.73
5159239-15923994.10394.62
6162939-16293996.29096.82
60min1165238-16523897.64896.821.4598.3197.491.44
2163215-16321596.45397.10
3165887-16588798.03298.72
4164290-16429097.08897.73
5159387-15938794.19194.87
6164973-16497397.49298.19
极限1168858-16885899.78799.180.99100.61100.010.98
2167628-16762899.06199.87
3168251-16825199.429100.29
4168684-16868499.685100.49
5164603-16460397.27398.11
6168935-16893599.833100.69
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