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%
112.114800484786374781964792624788874790060.15
212.104776104772584774340.06
单位质量响应值RSD%判断
39554.5839457.360.18数据可信
供试品溶液-24070801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%
5min1311599-31159956.61957.2911.9256.6257.2911.92
2361889-36188965.75765.76
3256679-25667946.64046.64
4294375-29437553.48953.49
5320770-32077058.28558.29
6346308-34630862.92662.93
10min1423675-42367576.98474.196.5877.0874.296.58
2430952-43095278.30678.42
3373097-37309767.79367.87
4388705-38870570.62970.72
5393488-39348871.49971.60
6440027-44002779.95580.06
15min1447711-44771181.35179.214.5681.5779.424.56
2450867-45086781.92582.16
3412489-41248974.95175.14
4423965-42396577.03677.24
5419250-41925076.18076.40
6461127-46112783.78984.03
20min1455473-45547382.76181.723.7083.1282.073.71
2461434-46143483.84584.22
3430601-43060178.24278.56
4442811-44281180.46180.80
5434593-43459378.96779.31
6473570-47357086.05086.43
30min1465138-46513884.51884.662.8885.0185.152.89
2474663-47466386.24886.76
3451055-45105581.95982.40
4464794-46479484.45584.92
5453229-45322982.35482.83
6486802-48680288.45488.98
45min1474363-47436386.19487.482.6486.8388.112.65
2487762-48776288.62989.29
3469622-46962285.33285.92
4485349-48534988.19088.80
5469540-46954085.31885.93
6501910-50191091.19991.87
60min1480632-48063287.33389.362.6388.1190.132.64
2495751-49575190.08090.89
3481716-48171687.53088.25
4500168-50016890.88391.64
5480592-48059287.32688.08
6511700-51170092.97893.80
极限1551037-551037100.12698.371.87101.0599.291.88
2545603-54560399.138100.10
3527882-52788295.91996.79
4539851-53985198.09399.00
5531571-53157196.58997.49
6552176-552176100.333101.31
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%
116.103053233056253059583056003061083057230.11
216.143062193061643061920.02
单位质量响应值RSD%判断
18989.0118971.000.07数据可信
供试品溶液-24070801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%
5min1133560-13356039.50339.379.8739.5039.379.87
2146576-14657643.35343.35
3109402-10940232.35832.36
4128927-12892738.13338.13
5138931-13893141.09241.09
6141278-14127841.78641.79
10min1233681-23368169.11663.637.3669.1863.707.36
2222465-22246565.79965.87
3191690-19169056.69756.75
4204427-20442760.46460.53
5210491-21049162.25762.33
6228112-22811267.46967.54
15min1276771-27677181.86174.746.2682.0474.926.26
2254090-25409075.15375.33
3235380-23538069.61969.77
4241708-24170871.49071.65
5243105-24310571.90472.08
6265209-26520978.44178.62
20min1295515-29551587.40581.315.0987.7281.605.10
2274837-27483781.28981.60
3260193-26019376.95877.22
4267305-26730579.06179.34
5263952-26395278.07078.36
6287551-28755185.04985.36
30min1308453-30845391.23288.033.5191.6988.463.52
2296776-29677687.77888.22
3287146-28714684.93085.32
4295479-29547987.39487.81
5286563-28656384.75785.18
6311425-31142592.11192.57
45min1313367-31336792.68591.722.6893.3092.302.69
2309158-30915891.44092.03
3302213-30221389.38689.92
4313566-31356692.74493.30
5299823-29982388.67989.24
6322500-32250095.38695.99
60min1314078-31407892.89592.472.5593.6793.202.56
2312071-31207192.30293.04
3305524-30552490.36591.05
4316930-31693093.73994.45
5302554-30255489.48790.20
6324652-32465296.02396.79
极限1332829-33282998.44196.722.0299.3797.612.03
2329713-32971397.52098.42
3317952-31795294.04194.88
4327115-32711596.75197.62
5320437-32043794.77695.64
6334059-33405998.80599.73
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