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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.651175551177441175461174661174801175580.10
213.641180011182411181210.15
单位质量响应值RSD%判断
8612.318659.900.39数据可信
供试品溶液-24070302SP批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118612-1861213.60712.1116.3713.6112.1116.36
213564-135649.9179.92
318054-1805413.19913.20
415300-1530011.18611.19
513816-1381610.10110.10
620053-2005314.66114.66
10min148064-4806435.14032.8111.3435.1632.8311.34
238644-3864428.25328.27
349389-4938936.10836.13
443023-4302331.45431.47
539763-3976329.07129.09
650398-5039836.84636.87
15min162860-6286045.95743.7110.1446.0443.7810.15
252972-5297238.72838.79
362474-6247445.67545.76
456760-5676041.49741.57
554642-5464239.94940.01
668994-6899450.44150.53
20min174585-7458554.52951.438.7754.6951.588.78
264276-6427646.99247.12
374126-7412654.19354.35
467926-6792649.66149.80
562981-6298146.04546.18
678155-7815557.13957.31
30min186665-8666563.36160.218.3763.6160.458.38
273901-7390154.02954.24
387404-8740463.90164.15
479840-7984058.37158.59
575616-7561655.28355.49
690742-9074266.34166.61
45min1101647-10164774.31469.786.2874.6770.126.30
288924-8892465.01265.31
397474-9747471.26371.62
494626-9462669.18169.50
588193-8819364.47864.78
6101850-10185074.46274.84
60min1107032-10703278.25176.025.4878.7376.475.50
297684-9768471.41771.82
3106915-10691578.16578.64
4103324-10332475.54075.98
597270-9727071.11471.52
6111675-11167581.64582.15
90min1114345-11434583.59881.213.4784.2181.793.50
2105659-10565977.24777.77
3111899-11189981.80982.41
4112653-11265382.36082.92
5107037-10703778.25578.78
6114881-11488183.98984.63
120min1119106-11910687.07883.873.5587.8384.583.57
2111410-11141081.45282.10
3115562-11556284.48785.23
4116620-11662085.26185.96
5108293-10829379.17379.83
6117314-11731485.76886.54
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1121126-12112688.55586.233.5889.4587.093.60
2113796-11379683.19683.98
3117627-11762785.99786.88
4121208-12120888.61589.46
5112024-11202481.90182.69
6121927-12192789.14190.06
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100651-202006对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.0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%
116.014714030471550947156644714202471561747150040.02
215.994741001474286247419320.03
单位质量响应值RSD%判断
294503.69296556.100.50数据可信
供试品溶液-24070302SP批-缬沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11368620-136862025.79025.748.1825.7925.748.18
21264384-126438423.82523.83
31444810-144481027.22527.23
41350348-135034825.44525.45
51233614-123361423.24623.25
61533571-153357128.89828.90
10min12241323-224132342.23442.037.6342.2842.077.64
22058703-205870338.79338.83
32361595-236159544.50144.55
42206310-220631041.57541.62
52038618-203861838.41538.45
62476129-247612946.65946.71
15min12819471-281947153.12952.687.6953.2452.807.69
22583497-258349748.68248.79
32884148-288414854.34754.47
42774899-277489952.28952.40
52565797-256579748.34948.45
63147623-314762359.31259.44
20min13238595-323859561.02660.336.3861.2360.536.38
23006317-300631756.65056.84
33299938-329993862.18262.39
43186717-318671760.04960.25
52959736-295973655.77255.96
63518328-351832866.29866.52
30min13831416-383141672.19771.205.5972.5071.505.60
23572262-357226267.31467.59
33872622-387262272.97473.29
43785414-378541471.33071.63
53515060-351506066.23666.51
64093544-409354477.13777.47
45min14367555-436755582.30081.454.4382.7281.874.44
24172386-417238678.62279.01
34386351-438635182.65483.09
44368836-436883682.32482.74
54044417-404441776.21176.60
64596324-459632486.61187.07
60min14655589-465558987.72887.493.4688.2988.043.47
24551003-455100385.75786.28
34675692-467569288.10688.68
44720987-472098788.96089.51
54390388-439038882.73083.24
64863833-486383391.65292.26
90min14905400-490540092.43593.452.5293.1494.152.53
24924117-492411792.78893.45
34921418-492141892.73793.46
45111580-511158096.32097.02
54790242-479024290.26590.92
65101569-510156996.13196.89
120min14987145-498714593.97595.522.3494.8496.382.34
25039269-503926994.95795.78
34997777-499777794.17695.05
45260598-526059899.12899.99
54963964-496396493.53894.34
65166828-516682897.36198.28
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15049407-504940795.14896.852.6296.1797.872.62
25094019-509401995.98996.97
35051856-505185695.19596.23
45347114-5347114100.758101.79
55026546-502654694.71895.68
65268927-526892799.285100.37
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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.651164911163961163561163421163991163970.05
213.641163601163211163400.03
单位质量响应值RSD%判断
8527.258529.330.02数据可信
供试品溶液-24070302SP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%
5min187426-8742664.72563.295.9364.7263.295.93
285720-8572063.46263.46
388576-8857665.57665.58
491024-9102467.38867.39
583696-8369661.96361.96
676484-7648456.62456.62
10min1100219-10021974.19671.915.5974.3072.015.60
296489-9648971.43471.54
3100742-10074274.58374.69
4101879-10187975.42575.54
596361-9636171.33971.44
687069-8706964.46064.55
15min1103684-10368476.76174.495.1476.9974.725.14
299283-9928373.50373.73
3103842-10384276.87877.11
4105450-10545078.06878.31
5100244-10024474.21474.44
691208-9120867.52567.73
20min1105262-10526277.92976.305.0578.2976.655.05
2103596-10359676.69677.04
3106763-10676379.04079.40
4106936-10693679.16979.54
5102846-10284676.14176.49
692989-9298968.84369.16
30min1108238-10823880.13278.014.7480.6278.494.74
2105518-10551878.11978.59
3108865-10886580.59781.09
4108724-10872480.49280.99
5105176-10517677.86678.34
695738-9573870.87871.31
45min1110423-11042381.75079.944.4182.3780.554.42
2108293-10829380.17380.78
3110850-11085082.06682.69
4111111-11111182.25982.89
5108669-10866980.45281.05
698557-9855772.96573.51
60min1109811-10981181.29779.404.5382.0680.144.53
2107545-10754579.61980.36
3109757-10975781.25782.02
4110497-11049781.80582.58
5108297-10829780.17680.91
697606-9760672.26172.93
90min1112202-11220283.06781.274.3083.9682.144.30
2111076-11107682.23483.11
3112427-11242783.23484.13
4111732-11173282.71983.63
5110955-11095582.14483.01
6100223-10022374.19974.99
120min1114021-11402184.41482.574.0785.4583.584.08
2112482-11248283.27484.28
3113933-11393384.34985.39
4113475-11347584.01085.06
5112951-11295183.62284.63
6102352-10235275.77576.69
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1115204-11520485.29083.703.6086.4684.853.61
2114217-11421784.55985.71
3114817-11481785.00386.18
4114338-11433884.64985.83
5114975-11497585.12086.27
6104806-10480677.59278.63
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100651-202006对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.0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%
116.014718823471711447168464715736471898847175010.03
215.994717316471727747172960.01
单位质量响应值RSD%判断
294659.65295015.380.09数据可信
供试品溶液-24070302SP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%
5min1198936-1989363.7573.732.093.763.732.10
2190374-1903743.5963.60
3202134-2021343.8183.82
4200411-2004113.7853.79
5197211-1972113.7253.72
6196133-1961333.7043.70
10min1494230-4942309.3359.141.709.349.151.71
2476875-4768759.0079.01
3486656-4866569.1929.20
4491961-4919619.2929.30
5480397-4803979.0749.08
6474162-4741628.9568.96
15min1695111-69511113.12912.971.7313.1512.991.73
2676304-67630412.77412.79
3693040-69304013.09013.11
4696336-69633613.15213.17
5691509-69150913.06113.08
6667504-66750412.60812.63
20min1864984-86498416.33716.111.7416.3816.161.73
2841670-84167015.89715.94
3860954-86095416.26116.30
4864121-86412116.32116.36
5858869-85886916.22216.27
6828361-82836115.64615.69
30min11132375-113237521.38821.281.9821.4621.351.97
21106401-110640120.89720.97
31143213-114321321.59221.66
41144267-114426721.61221.68
51141437-114143721.55921.63
61091594-109159420.61820.69
45min11448703-144870327.36227.241.7427.4727.351.74
21441962-144196227.23527.34
31453811-145381127.45927.57
41458491-145849127.54727.65
51457964-145796427.53727.64
61392951-139295126.30926.41
60min11706649-170664932.23432.121.8332.3932.271.84
21682834-168283431.78531.93
31716802-171680232.42632.58
41727543-172754332.62932.78
51724400-172440032.57032.72
61646482-164648231.09831.24
90min12098793-209879339.64139.511.5739.8539.721.57
22075252-207525239.19639.40
32110862-211086239.86940.08
42114582-211458239.93940.15
52118495-211849540.01340.22
62033099-203309938.40038.60
120min12404971-240497145.42445.231.7245.7045.501.72
22372364-237236444.80845.08
32405786-240578645.43945.71
42420609-242060945.71945.99
52440251-244025146.09046.36
62324168-232416843.89844.16
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12612313-261231349.34049.381.3449.6949.721.34
22596202-259620249.03649.38
32621531-262153149.51449.86
42622583-262258349.53449.88
52669414-266941450.41950.77
62563197-256319748.41248.75
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