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(%)99.70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%
112.114769844764694763044762184762224764390.07
212.104721984718164720070.06
单位质量响应值RSD%判断
39342.6139008.840.61数据可信
供试品溶液-24071701批-氢氯噻嗪-pH6.8(内含0.35%吐温20)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1164817-16481730.20135.3521.2130.2035.3421.20
2206893-20689337.91137.91
3187581-18758134.37234.37
4168500-16850030.87630.88
5160939-16093929.49029.49
6268627-26862749.22349.22
10min1323961-32396159.36260.919.6459.4160.979.65
2351085-35108564.33364.40
3333417-33341761.09561.15
4324647-32464759.48859.54
5282466-28246651.75951.81
6378829-37882969.41669.50
15min1417507-41750776.50473.906.3376.6574.066.34
2422938-42293877.49977.67
3402422-40242273.74073.90
4404020-40402074.03274.18
5354081-35408164.88265.02
6418939-41893976.76676.96
20min1452563-45256382.92780.444.1083.2080.724.10
2455803-45580383.52183.82
3436339-43633979.95480.24
4444923-44492381.52781.80
5405759-40575974.35174.59
6438491-43849180.34980.67
30min1484190-48419088.72386.602.3289.1487.022.32
2481374-48137488.20788.65
3474799-47479987.00287.42
4476466-47646687.30787.72
5456554-45655483.65984.03
6462131-46213184.68185.14
45min1506595-50659592.82890.172.1693.3990.732.14
2493929-49392990.50791.09
3495819-49581990.85391.41
4496613-49661390.99991.55
5482275-48227588.37288.88
6477364-47736487.47288.07
60min1522153-52215395.67992.232.6796.4092.942.66
2500947-50094791.79392.53
3507963-50796393.07993.79
4511810-51181093.78494.49
5491346-49134690.03490.69
6485852-48585289.02789.77
极限1541726-54172699.26598.661.19100.1499.531.19
2538635-53863598.69999.59
3527204-52720496.60497.47
4540929-54092999.11999.98
5536320-53632098.27599.08
6545810-545810100.014100.91
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%
116.103100203098233098863100963100093099670.04
216.143073603071393072500.06
单位质量响应值RSD%判断
19252.6119036.560.80数据可信
供试品溶液-24071701批-坎地沙坦酯-pH6.8(内含0.35%吐温20)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min172042-7204221.12523.9120.4621.1323.9120.46
283442-8344224.46824.47
379493-7949323.31023.31
472922-7292221.38421.38
567777-6777719.87519.87
6113634-11363433.32233.32
10min1165658-16565848.57749.4011.3048.6149.4411.31
2173205-17320550.79050.83
3166006-16600648.67948.72
4163862-16386248.05148.09
5141485-14148541.48941.52
6200482-20048258.78958.84
15min1233286-23328668.40866.067.4968.5266.187.50
2231973-23197368.02368.15
3222904-22290465.36465.48
4227232-22723266.63366.75
5193613-19361356.77556.88
6242674-24267471.16171.31
20min1272172-27217279.81176.545.4380.0476.775.43
2267849-26784978.54478.78
3258370-25837075.76475.99
4267653-26765378.48678.71
5233620-23362068.50668.70
6266356-26635678.10678.38
30min1306985-30698590.02086.893.8090.3887.253.80
2301511-30151188.41588.78
3298780-29878087.61487.97
4304516-30451689.29689.65
5277194-27719481.28481.60
6288973-28897384.73885.14
45min1327272-32727295.96992.123.3796.4892.623.36
2314393-31439392.19292.71
3318089-31808993.27693.78
4321778-32177894.35894.86
5302275-30227588.63989.09
6300983-30098388.26088.80
60min1333241-33324197.71993.623.6098.3994.283.59
2318325-31832593.34594.02
3323707-32370794.92395.58
4328448-32844896.31496.98
5307097-30709790.05390.65
6304733-30473389.35990.05
极限1335559-33555998.39997.841.1399.2398.661.14
2334114-33411497.97598.80
3327031-32703195.89896.71
4335198-33519898.29399.12
5332163-33216397.40398.15
6337926-33792699.09399.93
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