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%
112.314650224649394648664646464645884648120.05
212.334663894664054663970.01
单位质量响应值RSD%判断
37758.9037826.200.13数据可信
供试品溶液-2批-氢氯噻嗪-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%
5min1240877-24087745.75346.6611.9745.7546.6611.97
2253702-25370248.18948.19
3229838-22983843.65643.66
4252447-25244747.95047.95
5204194-20419438.78538.79
6292720-29272055.60055.60
10min1410605-41060577.99178.243.9978.0778.324.00
2423575-42357580.45580.54
3404215-40421576.77876.85
4412169-41216978.28878.37
5386454-38645473.40473.47
6434324-43432482.49782.59
15min1473066-47306689.85588.932.4490.0689.142.45
2475563-47556390.33090.54
3473706-47370689.97790.18
4466670-46667088.64088.85
5445810-44581084.67884.87
6474468-47446890.12290.35
20min1489588-48958892.99492.691.1993.3593.051.20
2489413-48941392.96093.33
3492196-49219693.48993.84
4489054-48905492.89293.25
5476406-47640690.49090.82
6491264-49126493.31293.69
30min1504142-50414295.75895.540.7696.2796.050.76
2506773-50677396.25896.78
3505985-50598596.10896.61
4501379-50137995.23395.75
5496357-49635794.27994.76
6503348-50334895.60796.14
45min1516759-51675998.15497.970.9098.8398.640.91
2521018-52101898.96399.64
3517628-51762898.31998.99
4514071-51407197.64498.32
5507581-50758196.41197.05
6517759-51775998.34499.04
60min1526738-526738100.05099.470.91100.88100.300.93
2526477-526477100.000100.85
3526373-52637399.981100.81
4521256-52125699.00999.84
5514977-51497797.81698.61
6526376-52637699.981100.84
极限1535219-535219101.661101.430.83102.66102.430.84
2536842-536842101.969102.98
3535654-535654101.743102.74
4530527-530527100.770101.77
5527001-527001100.100101.06
6538863-538863102.353103.38
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%
116.133266033289363266913286163295993280890.42
216.09 3260543260833260680.01
单位质量响应值RSD%判断
20340.3020265.260.27数据可信
供试品溶液-2批-坎地沙坦酯-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.15244.950.000.15244.95
2-0.0000.00
33276-32760.9060.91
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min13309-33090.9150.8351.280.910.8351.35
2-0.0000.00
34379-43791.2111.21
43121-31210.8630.86
53853-38531.0651.07
63376-33760.9330.93
45min14343-43431.2011.2314.881.201.2414.89
23882-38821.0731.07
35565-55651.5391.54
44065-40651.1241.13
54943-49431.3671.37
63971-39711.0981.10
60min15230-52301.4461.459.101.451.459.03
25073-50731.4031.40
36144-61441.6991.70
44753-47531.3141.32
55183-51831.4331.44
65022-50221.3891.39
极限15606-56061.5501.5610.471.561.5710.49
25406-54061.4951.50
36546-65461.8101.82
45151-51511.4241.43
56158-61581.7031.71
65037-50371.3931.40
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