缬沙坦左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
114.131221211217501217351217051215701217760.17
214.081202131204861203500.17
单位质量响应值RSD%判断
8618.268547.590.59数据可信
供试品溶液-25071001批-左氨氯地平-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1102006-102006104.07797.699.37104.0897.699.37
290938-9093892.78492.78
3101485-101485103.545103.55
499042-99042101.052101.05
5101467-101467103.527103.53
679531-7953181.14581.15
10min1108424-108424110.625109.571.26110.80109.731.27
2105376-105376107.515107.67
3108496-108496110.698110.87
4106027-106027108.179108.35
5108305-108305110.504110.68
6107710-107710109.896110.03
15min1110997-110997113.250111.651.46113.61112.001.47
2107120-107120109.294109.63
3110414-110414112.655113.01
4107892-107892110.082110.43
5110701-110701112.948113.30
6109455-109455111.677112.00
20min1111835-111835114.105112.631.58114.65113.161.58
2107623-107623109.808110.32
3111709-111709113.977114.52
4108955-108955111.167111.70
5111593-111593113.858114.40
6110635-110635112.881113.39
30min1113824-113824116.135114.171.72116.87114.881.72
2109414-109414111.635112.33
3113229-113229115.527116.26
4109651-109651111.877112.59
5113188-113188115.486116.22
6112066-112066114.341115.03
45min1114519-114519116.844115.171.53117.77116.081.53
2110181-110181112.418113.30
3114317-114317116.638117.56
4111716-111716113.984114.89
5114013-114013116.327117.25
6112516-112516114.800115.68
60min1116083-116083118.439116.041.88119.56117.141.88
2111620-111620113.886114.96
3115363-115363117.705118.83
4112392-112392114.673115.77
5115471-115471117.815118.94
6111441-111441113.703114.78
90min1117617-117617120.005118.441.56121.33119.741.57
2113497-113497115.801117.06
3117412-117412119.795121.11
4114485-114485116.809118.09
5117762-117762120.152121.47
6115745-115745118.095119.36
120min1118325-118325120.727119.161.52122.25120.661.53
2114172-114172116.490117.94
3117995-117995120.390121.91
4115504-115504117.849119.33
5118532-118532120.938122.46
6116234-116234118.593120.05
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1119105-119105121.523119.941.72123.25121.631.72
2114446-114446116.769118.42
3119312-119312121.734123.45
4116133-116133118.490120.17
5119246-119246121.667123.39
6117070-117070119.446121.10
缬沙坦左氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
115.964704513469980846967924696513469213646979520.10
215.954656221465720646567140.02
单位质量响应值RSD%判断
294357.89291956.990.58数据可信
供试品溶液-25071001批-缬沙坦-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1218648-2186484.1584.6010.894.164.6010.88
2291943-2919435.5515.55
3223165-2231654.2444.24
4244206-2442064.6444.64
5239570-2395704.5554.56
6233897-2338974.4484.45
10min1480599-4805999.1399.482.659.159.492.63
2499671-4996719.5019.51
3486473-4864739.2509.26
4511399-5113999.7249.73
5513695-5136959.7689.78
6500483-5004839.5179.52
15min1701664-70166413.34213.762.0713.3613.792.07
2716808-71680813.63013.66
3716441-71644113.62313.65
4738183-73818314.03714.06
5740592-74059214.08314.11
6729390-72939013.87013.89
20min1884042-88404216.81017.664.4516.8517.714.44
21003505-100350519.08219.13
3900912-90091217.13117.18
4929295-92929517.67117.72
5935755-93575517.79417.84
6918931-91893117.47417.52
30min11191145-119114522.65023.061.6022.7223.141.60
21202644-120264422.86922.95
31200087-120008722.82022.89
41216084-121608423.12423.20
51244932-124493223.67323.75
61221842-122184223.23423.31
45min11538240-153824029.25029.801.5829.3629.911.58
21545269-154526929.38429.50
31557565-155756529.61829.73
41581142-158114230.06630.18
51604063-160406330.50230.62
61575974-157597429.96830.08
60min11813831-181383134.49034.971.4134.6535.141.41
21819128-181912834.59134.76
31826921-182692134.73934.90
41844561-184456135.07535.24
51884968-188496835.84336.01
61845342-184534235.09035.25
90min12207772-220777241.98142.671.5742.2042.901.57
22215298-221529842.12442.35
32227521-222752142.35742.58
42252012-225201242.82343.05
52302531-230253143.78344.01
62259886-225988642.97243.20
120min12510954-251095447.74648.361.5048.0348.651.50
22506829-250682947.66847.96
32525733-252573348.02748.32
42546783-254678348.42848.72
52608660-260866049.60449.90
62560339-256033948.68648.98
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限12694402-269440251.23551.851.2851.6052.221.28
22691145-269114551.17351.55
32716425-271642551.65452.02
42727118-272711851.85752.23
52783202-278320252.92353.31
62746780-274678052.23152.61
缬沙坦左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
114.131213201212981208621209351212531211340.18
214.081208391207491207940.06
单位质量响应值RSD%判断
8572.828579.120.06数据可信
供试品溶液-25071002批-左氨氯地平-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min187879-8787989.73488.561.4889.7388.561.48
287003-8700388.84088.84
388332-8833290.19790.20
486577-8657788.40588.40
585393-8539387.19687.20
685191-8519186.98986.99
10min195354-9535497.36797.081.5097.5297.231.51
295694-9569497.71497.86
397067-9706799.11699.27
495496-9549697.51297.66
593240-9324095.20895.35
693602-9360295.57895.72
15min198425-98425100.503100.331.14100.81100.641.14
298916-98916101.004101.31
399805-99805101.912102.23
498417-98417100.494100.80
596758-9675898.80099.10
697235-9723599.28899.59
20min1100250-100250102.366101.961.86102.85102.441.85
2100119-100119102.232102.71
3102260-102260104.419104.90
4100935-100935103.066103.54
596988-9698899.03599.50
698557-98557100.637101.11
30min1102372-102372104.533104.571.03105.18105.221.03
2103067-103067105.243105.89
3103839-103839106.031106.69
4102745-102745104.914105.56
5101060-101060103.193103.83
6101366-101366103.506104.14
45min1105120-105120107.339107.791.22108.16108.611.22
2106154-106154108.395109.22
3107687-107687109.960110.80
4105718-105718107.950108.77
5104097-104097106.294107.10
6104568-104568106.775107.59
60min1107597-107597109.868109.821.30110.87110.821.30
2108284-108284110.570111.58
3109725-109725112.041113.06
4107560-107560109.830110.83
5105878-105878108.113109.10
6106279-106279108.522109.51
90min1110341-110341112.670112.821.30113.86114.011.31
2111943-111943114.306115.50
3112388-112388114.760115.97
4110274-110274112.602113.79
5108833-108833111.130112.29
6109157-109157111.461112.63
120min1111988-111988114.352114.481.40115.73115.861.40
2113639-113639116.038117.42
3114087-114087116.495117.89
4112208-112208114.577115.95
5110255-110255112.582113.93
6110531-110531112.864114.22
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1112939-112939115.323115.541.43116.89117.101.43
2114518-114518116.935118.51
3115321-115321117.755119.35
4113323-113323115.715117.28
5111058-111058113.402114.94
6111756-111756114.115115.66
缬沙坦左氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
115.964685760468949446828864685487468974746866750.07
215.954680175468474446824600.07
单位质量响应值RSD%判断
293651.32293571.160.02数据可信
供试品溶液-25071002批-缬沙坦-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1228073-2280734.3304.173.694.334.173.74
2208222-2082223.9533.95
3217173-2171734.1234.12
4219374-2193744.1654.16
5229951-2299514.3664.37
6215909-2159094.0994.10
10min1469693-4696938.9178.771.708.928.781.70
2451804-4518048.5788.58
3463851-4638518.8068.81
4452595-4525958.5938.60
5468528-4685288.8958.90
6465416-4654168.8368.84
15min1673913-67391312.79512.651.3612.8212.681.35
2660750-66075012.54512.57
3665673-66567312.63812.66
4651853-65185312.37612.40
5676049-67604912.83512.86
6669817-66981712.71712.74
20min1843253-84325316.01015.891.3216.0515.931.32
2835391-83539115.86015.90
3838608-83860815.92115.96
4815837-81583715.48915.53
5845892-84589216.06016.10
6842883-84288316.00316.05
30min11120125-112012521.26621.141.1521.3421.221.16
21119542-111954221.25521.32
31112799-111279921.12721.20
41088339-108833920.66320.73
51120693-112069321.27721.35
61120947-112094721.28221.35
45min11446319-144631927.45927.331.1527.5627.431.16
21452590-145259027.57827.68
31434832-143483227.24127.35
41407938-140793826.73026.83
51446341-144634127.46027.57
61448657-144865727.50427.61
60min11708812-170881232.44332.211.3432.5932.361.34
21717087-171708732.60032.75
31689967-168996732.08532.23
41654243-165424331.40731.55
51704445-170444532.36032.51
61705549-170554932.38132.53
90min12106864-210686440.00039.681.3040.2139.881.30
22116813-211681340.18940.39
32080553-208055339.50039.70
42041396-204139638.75738.96
52088404-208840439.65039.85
62105117-210511739.96740.17
120min12423277-242327746.00745.651.0646.2845.921.07
22428397-242839746.10446.38
32394691-239469145.46545.73
42358998-235899844.78745.05
52404425-240442545.64945.92
62416762-241676245.88446.15
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限12596246-259624649.29149.121.0449.6449.461.04
22610422-261042249.56049.91
32583787-258378749.05549.40
42535632-253563248.14048.48
52592261-259226149.21649.56
62603904-260390449.43749.78
缬沙坦左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
114.131214001213671216231211601218921214880.23
214.081199121201431200280.14
单位质量响应值RSD%判断
8597.888524.720.61数据可信
供试品溶液-25071001批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min180582-8058282.42685.873.5682.4385.873.56
286750-8675088.73588.73
385124-8512487.07187.07
487598-8759889.60289.60
580892-8089282.74382.74
682773-8277384.66784.67
10min190455-9045592.52496.633.9392.6696.783.93
299657-99657101.937102.08
394398-9439896.55896.70
497979-97979100.221100.37
590998-9099893.08093.22
693348-9334895.48495.62
15min195162-9516297.339101.053.3797.63101.363.37
2103192-103192105.553105.87
398744-98744101.003101.31
4102015-102015104.349104.67
595314-9531497.49597.79
698315-98315100.564100.86
20min198211-98211100.458103.963.53100.91104.433.53
2106578-106578109.016109.51
3101171-101171103.486103.96
4105073-105073107.477107.97
597684-9768499.919100.37
6101098-101098103.411103.88
30min1101378-101378103.697107.593.48104.32108.233.48
2110259-110259112.781113.46
3104045-104045106.425107.07
4108680-108680111.166111.84
5101583-101583103.907104.53
6105136-105136107.541108.18
45min1103818-103818106.193110.022.88106.99110.842.88
2108934-108934111.426112.29
3107273-107273109.727110.55
4112124-112124114.689115.54
5104461-104461106.851107.65
6108738-108738111.226112.05
60min1106675-106675109.115112.953.29110.09113.963.29
2115860-115860118.511119.56
3109310-109310111.811112.82
4113095-113095115.682116.73
5106747-106747109.189110.16
6110850-110850113.386114.39
90min1109865-109865112.378115.183.76113.53116.373.75
2118899-118899121.619122.87
3111895-111895114.455115.65
4116645-116645119.314120.55
5110038-110038112.555113.71
6108261-108261110.738111.93
120min1112212-112212114.779118.523.02116.12119.913.02
2121140-121140123.911125.36
3114625-114625117.247118.63
4118529-118529121.241122.68
5112548-112548115.123116.47
6116185-116185118.843120.22
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1113221-113221115.811118.633.27117.34120.223.26
2121938-121938124.728126.38
3115045-115045117.677119.26
4119338-119338122.068123.71
5113566-113566116.164117.70
6112749-112749115.328116.90
缬沙坦左氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
115.964706046470457447032604700934470263647034900.05
215.954669658467141346705360.03
单位质量响应值RSD%判断
294704.89292823.570.46数据可信
供试品溶液-25071001批-缬沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1225220-2252204.2744.233.844.274.233.87
2219321-2193214.1624.16
3231627-2316274.3954.40
4211948-2119484.0224.02
5233481-2334814.4314.43
6216668-2166684.1114.11
10min1482444-4824449.1559.302.319.169.312.32
2494634-4946349.3869.39
3490797-4907979.3139.32
4472588-4725888.9688.97
5504957-5049579.5829.59
6495600-4956009.4049.41
15min1709146-70914613.45713.662.1613.4813.682.17
2718573-71857313.63613.66
3721489-72148913.69113.71
4696705-69670513.22113.24
5737592-73759213.99614.02
6735322-73532213.95313.98
20min1902919-90291917.13417.312.6117.1817.362.60
2915662-91566217.37517.42
3885450-88545016.80216.85
4889985-88998516.88816.93
5939912-93991217.83617.88
6939384-93938417.82617.87
30min11212709-121270923.01223.352.1823.0923.422.18
21234944-123494423.43423.51
31211822-121182222.99523.07
41199635-119963522.76422.84
51261721-126172123.94224.02
61261870-126187023.94524.02
45min11557600-155760029.55730.072.8629.6730.182.85
21533453-153345329.09929.21
31578870-157887029.96030.07
41559210-155921029.58729.70
51628725-162872530.90631.02
61649765-164976531.30631.42
60min11840898-184089834.93335.632.6335.0935.792.63
21883517-188351735.74135.90
31851129-185112935.12735.29
41820819-182081934.55234.71
51921151-192115136.45636.62
61948138-194813836.96837.14
90min12239544-223954442.49742.902.0342.7243.122.03
22291966-229196643.49243.71
32252490-225249042.74342.96
42232543-223254342.36442.58
52337238-233723844.35144.58
62211837-221183741.97242.20
120min12551649-255164948.42049.322.2248.7149.612.22
22602835-260283549.39149.68
32572166-257216648.80949.10
42535881-253588148.12148.41
52645502-264550250.20150.50
62685331-268533150.95651.26
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限12740645-274064552.00652.752.0352.3853.132.02
22787038-278703852.88653.26
32733643-273364351.87352.25
42725046-272504651.71052.08
52834789-283478953.79354.18
62857603-285760354.22654.61
缬沙坦左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
114.131217111216521216501216441222471217810.22
214.081211651212711212180.07
单位质量响应值RSD%判断
8618.618609.230.08数据可信
供试品溶液-25071002批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min182461-8246183.83181.912.7783.8381.912.77
279109-7910980.42380.42
382372-8237283.74083.74
480206-8020681.53881.54
582303-8230383.67083.67
676994-7699478.27378.27
10min191679-9167993.20291.552.1193.3491.692.11
288409-8840989.87790.01
392103-9210393.63393.77
489817-8981791.30991.44
591021-9102192.53392.67
687319-8731988.76988.90
15min195638-9563897.22795.602.6197.5295.892.61
292394-9239493.92994.21
396284-9628497.88398.18
494658-9465896.23096.52
595397-9539796.98297.28
689850-8985091.34291.62
20min198459-98459100.09498.781.73100.5599.221.73
295279-9527996.86297.30
398949-98949100.593101.05
497548-9754899.16899.62
597816-9781699.44199.90
694921-9492196.49896.93
30min1101815-101815103.506102.131.96104.13102.741.95
297594-9759499.21599.82
3102372-102372104.072104.70
4101035-101035102.713103.33
5101497-101497103.183103.80
698440-98440100.075100.67
45min1105650-105650107.405106.252.05108.20107.032.05
2102732-102732104.438105.21
3106232-106232107.997108.80
4105282-105282107.031107.82
5106152-106152107.915108.71
6101026-101026102.704103.46
60min1108481-108481110.283108.462.81111.26109.422.80
2104504-104504106.240107.18
3108516-108516110.318111.30
4108053-108053109.848110.81
5108982-108982110.792111.77
6101569-101569103.256104.19
90min1111595-111595113.449112.571.80114.61113.721.80
2108646-108646110.451111.57
3112219-112219114.083115.25
4111880-111880113.738114.88
5112281-112281114.146115.30
6107786-107786109.576110.68
120min1114324-114324116.223115.231.69117.57116.561.69
2111684-111684113.539114.84
3114872-114872116.780118.13
4113912-113912115.804117.14
5114988-114988116.898118.25
6110326-110326112.159113.44
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1115261-115261117.176116.241.58118.72117.761.58
2113000-113000114.877116.37
3115792-115792117.715119.26
4114636-114636116.540118.07
5115966-115966117.892119.43
6111390-111390113.240114.71
缬沙坦左氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
115.964709880470913947101374711032470991447100200.02
215.954721353472212447217380.02
单位质量响应值RSD%判断
295114.04296033.730.23数据可信
供试品溶液-25071002批-缬沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1221813-2218134.1834.056.334.184.056.27
2221370-2213704.1754.17
3227204-2272044.2854.28
4198203-1982033.7383.74
5223454-2234544.2144.21
6196729-1967293.7103.71
10min1470030-4700308.8658.633.878.878.643.85
2463335-4633358.7388.75
3470515-4705158.8748.88
4437565-4375658.2528.26
5471128-4711288.8858.89
6432613-4326138.1598.17
15min1683667-68366712.89412.662.8912.9212.682.90
2676072-67607212.75012.77
3685040-68504012.92012.94
4652447-65244712.30512.32
5688827-68882712.99113.01
6642271-64227112.11312.13
20min1861650-86165016.25016.012.1216.2916.052.11
2845960-84596015.95416.00
3862315-86231516.26316.31
4831698-83169815.68515.73
5867453-86745316.36016.40
6824148-82414815.54315.58
30min11143950-114395021.57421.471.8921.6421.541.89
21141061-114106121.52021.59
31152073-115207321.72821.80
41120026-112002621.12321.19
51165306-116530621.97722.05
61106726-110672620.87220.94
45min11483561-148356127.97927.891.8328.0927.991.83
21471974-147197427.76127.87
31492403-149240328.14628.25
41469787-146978727.72027.82
51517818-151781828.62528.73
61436421-143642127.09027.19
60min11758981-175898133.17432.921.9233.3333.071.91
21721953-172195332.47532.63
31753423-175342333.06933.22
41740981-174098132.83432.98
51797389-179738933.89834.05
61700189-170018932.06532.21
90min12165619-216561940.84340.741.6341.0540.941.63
22145912-214591240.47140.68
32169220-216922040.91041.12
42158367-215836740.70640.91
52214386-221438641.76241.97
62106307-210630739.72439.92
120min12483776-248377646.84346.661.3647.1246.941.37
22455600-245560046.31146.58
32484873-248487346.86447.14
42455660-245566046.31346.58
52530744-253074447.72948.01
62435277-243527745.92846.19
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限12653621-265362150.04650.031.2750.4050.381.27
22637817-263781749.74850.10
32669267-266926750.34150.70
42631712-263171249.63349.98
52709505-270950551.10051.46
62614470-261447049.30849.65
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