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%
111.854736004736144737284737684737354736890.02
211.834757754757864757800.01
单位质量响应值RSD%判断
39973.7640218.090.44数据可信
供试品溶液-2024082321批-氢氯噻嗪-0.35tw20
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1341133-34113361.07459.3815.0061.0759.3815.00
2356037-35603763.74263.74
3387128-38712869.30869.31
4364634-36463465.28165.28
5275720-27572049.36349.36
6265450-26545047.52447.52
10min1450370-45037080.63178.367.2080.7378.467.20
2442150-44215079.15979.27
3473723-47372384.81284.93
4457860-45786081.97282.08
5414700-41470074.24574.33
6387315-38731569.34269.42
15min1475369-47536985.10684.134.0385.3484.364.04
2464093-46409383.08883.33
3495519-49551988.71488.97
4482694-48269486.41886.66
5460540-46054082.45282.66
6441340-44134079.01479.21
20min1492726-49272688.21486.803.1888.5987.183.20
2476331-47633185.27985.66
3505570-50557090.51390.92
4494548-49454888.54088.93
5476535-47653585.31585.66
6463424-46342482.96883.29
30min1506695-50669590.71589.962.1391.2490.482.15
2492210-49221088.12288.64
3518413-51841392.81393.37
4509597-50959791.23491.77
5494208-49420888.47988.96
6493814-49381488.40988.87
45min1518470-51847092.82392.102.0293.5092.762.04
2501652-50165289.81290.48
3528026-52802694.53495.24
4523214-52321493.67294.36
5506308-50630890.64691.28
6508786-50878691.08991.70
60min1524350-52435093.87692.871.9994.7193.692.00
2504702-50470290.35891.17
3530919-53091995.05295.92
4526699-52669994.29695.14
5509826-50982691.27592.06
6515843-51584392.35393.12
极限1549934-54993498.45698.030.5099.4499.000.48
2543581-54358197.31998.28
3546508-54650897.84398.87
4546937-54693797.91998.92
5547130-54713097.95498.89
6551281-55128198.69799.61
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%
116.171497491498051497801498191497001497710.04
216.121502901502211502560.04
单位质量响应值RSD%判断
9262.289321.090.45数据可信
供试品溶液-2024082321批-坎地沙坦酯-0.35tw20
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min166866-6686640.39939.8813.8840.4039.8813.88
270511-7051142.60142.60
376246-7624646.06646.07
472420-7242043.75443.75
557130-5713034.51734.52
652835-5283531.92231.92
10min1105229-10522963.57763.036.4563.6463.106.46
2106202-10620264.16564.24
3111424-11142467.32067.40
4110398-11039866.70066.77
598239-9823959.35459.41
694451-9445157.06557.12
15min1120786-12078672.97672.943.2673.1573.123.27
2118993-11899371.89372.07
3125654-12565475.91776.11
4124919-12491975.47375.66
5118574-11857471.63971.80
6115470-11547069.76469.91
20min1128711-12871177.76478.072.3378.0678.362.34
2126244-12624476.27476.57
3133263-13326380.51480.83
4132533-13253380.07380.38
5128022-12802277.34877.62
6126558-12655876.46376.73
30min1137411-13741183.02083.501.8483.4483.921.84
2134396-13439681.19981.62
3141104-14110485.25285.70
4140933-14093385.14885.59
5137154-13715482.86583.27
6138273-13827383.54183.93
45min1142976-14297686.38386.551.7886.9587.121.78
2139410-13941084.22884.79
3146161-14616188.30788.90
4145949-14594988.17988.76
5141969-14196985.77486.32
6143071-14307186.44086.97
60min1145711-14571188.03587.791.7788.7488.501.77
2141538-14153885.51486.21
3148301-14830189.60090.34
4147809-14780989.30390.03
5143552-14355286.73187.42
6144963-14496387.58388.26
极限1153454-15345492.71392.040.7293.5792.900.72
2150563-15056390.96691.81
3153181-15318192.54893.44
4152809-15280992.32393.20
5151621-15162191.60692.44
6152440-15244092.10092.92
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