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%
113.651183011184431183011182741183041183250.06
213.641183031183471183250.03
单位质量响应值RSD%判断
8668.508674.850.06数据可信
供试品溶液-1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%
5min193558-9355868.11972.104.6068.1272.104.60
298345-9834571.60471.60
399582-9958272.50572.51
4106892-10689277.82777.83
599900-9990072.73772.74
695839-9583969.78069.78
10min1103547-10354775.39278.544.4675.5178.664.46
2106677-10667777.67177.79
3109006-10900679.36779.49
4116751-11675185.00685.14
5107213-10721378.06178.18
6104038-10403875.74975.87
15min1106014-10601477.18880.304.1977.4380.554.20
2108743-10874379.17579.42
3111429-11142981.13181.38
4118616-11861686.36486.64
5110527-11052780.47480.73
6106376-10637677.45277.69
20min1107315-10731578.13580.993.9178.5081.383.92
2110315-11031580.32080.70
3112758-11275882.09882.49
4118714-11871486.43586.85
5111560-11156081.22681.61
6106763-10676377.73478.11
30min1108739-10873979.17282.244.0979.6782.764.09
2111252-11125281.00281.52
3114056-11405683.04483.57
4121301-12130188.31988.88
5113238-11323882.44882.97
6109105-10910579.43979.94
45min1110550-11055080.49183.824.0581.1284.484.04
2117381-11738185.46486.11
3115547-11554784.12984.79
4122641-12264189.29490.00
5114549-11454983.40284.06
6110105-11010580.16780.80
60min1111736-11173681.35484.083.8382.1284.873.83
2114296-11429683.21884.01
3117227-11722785.35286.16
4123106-12310689.63390.49
5115543-11554384.12684.92
6110933-11093380.77081.54
90min1113377-11337782.54985.113.7283.4586.043.73
2115593-11559384.16385.09
3118181-11818186.04786.99
4124713-12471390.80391.81
5116753-11675385.00785.94
6112721-11272182.07282.97
120min1110685-11068580.58985.164.4181.6386.244.41
2116254-11625484.64485.71
3118666-11866686.40087.49
4125523-12552391.39392.55
5117713-11771385.70686.79
6112930-11293082.22483.26
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1114761-11476183.55785.953.9184.7387.183.92
2114563-11456383.41384.62
3120019-12001987.38588.62
4126121-12612191.82893.14
5118579-11857986.33787.56
6114275-11427583.20384.38
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%
116.014677871467425646776134676834467899246771130.04
215.994683322468548246844020.04
单位质量响应值RSD%判断
292136.98292958.220.20数据可信
供试品溶液-1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%
5min1316546-3165466.0266.402.976.036.402.96
2342806-3428066.5256.53
3337524-3375246.4256.42
4341032-3410326.4926.49
5336412-3364126.4046.40
6342785-3427856.5256.53
10min1623834-62383411.87511.951.0011.8811.961.01
2631284-63128412.01712.03
3632448-63244812.03912.05
4635406-63540612.09512.11
5623898-62389811.87611.89
6619363-61936311.79011.80
15min1826694-82669415.73616.201.6415.7716.231.64
2859707-85970716.36516.40
3860445-86044516.37916.41
4863914-86391416.44516.48
5850555-85055516.19116.22
6844111-84411116.06816.10
20min11008943-100894319.20619.761.6319.2619.821.63
21050903-105090320.00420.06
31051239-105123920.01120.07
41051097-105109720.00820.07
51032422-103242219.65319.71
61032791-103279119.66019.72
30min11296075-129607524.67125.351.3824.7625.441.38
21341818-134181825.54225.63
31347416-134741625.64925.74
41338237-133823725.47425.57
51334917-133491725.41125.50
61333104-133310425.37625.47
45min11623619-162361930.90631.802.1231.0431.932.12
21729040-172904032.91333.05
31683846-168384632.05332.19
41668772-166877231.76631.90
51667543-166754331.74231.87
61649229-164922931.39431.53
60min11883953-188395335.86236.661.3636.0436.851.36
21940326-194032636.93537.12
31959777-195977737.30537.49
41928146-192814636.70336.89
51933516-193351636.80536.99
61910668-191066836.37036.56
90min12275127-227512743.30844.171.2843.5544.421.28
22350007-235000744.73344.98
32347156-234715644.67944.93
42327164-232716444.29944.55
52327108-232710844.29744.54
62295200-229520043.69043.94
120min12608701-260870149.65849.930.8749.9750.250.88
22648854-264885450.42250.75
32644238-264423850.33450.66
42622413-262241349.91950.24
52625362-262536249.97550.30
62587396-258739649.25249.57
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12735010-273501052.06253.261.3852.4653.661.38
22790061-279006153.11053.52
32846554-284655454.18554.59
42815943-281594353.60354.01
52819373-281937353.66854.07
62781232-278123252.94253.34
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%
113.651182641182381182791182281181851182390.04
213.641171881170661171270.08
单位质量响应值RSD%判断
8662.208587.020.62数据可信
供试品溶液-2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%
5min193973-9397368.79670.672.4268.8070.662.42
298788-9878872.32172.32
396975-9697570.99470.99
499201-9920172.62372.62
596575-9657570.70170.70
693655-9365568.56368.56
10min1101278-10127874.14477.723.0974.2677.843.08
2106285-10628577.80977.93
3104461-10446176.47476.59
4108374-10837479.33979.46
5110822-11082281.13181.25
6105752-10575277.41977.53
15min1103528-10352875.79179.573.1376.0379.823.13
2108225-10822579.23079.48
3106781-10678178.17278.42
4110858-11085881.15781.41
5113401-11340183.01983.27
6109339-10933980.04580.29
20min1104447-10444776.46480.483.2076.8380.863.20
2109656-10965680.27780.66
3108024-10802479.08279.46
4112370-11237082.26482.65
5114588-11458883.88884.28
6110497-11049780.89381.27
30min1105708-10570877.38781.473.1377.8881.983.13
2110461-11046180.86681.38
3109697-10969780.30780.82
4114186-11418683.59384.12
5115398-11539884.48185.01
6112253-11225382.17882.69
45min1107672-10767278.82582.993.2879.4583.643.27
2112009-11200982.00082.65
3111595-11159581.69782.34
4115427-11542784.50285.17
5118242-11824286.56387.23
6115239-11523984.36485.01
60min1107992-10799279.05983.493.2479.8184.283.23
2113033-11303382.74983.54
3112488-11248882.35083.13
4116575-11657585.34286.15
5118276-11827686.58887.40
6115908-11590884.85485.64
90min1109410-10941080.09784.363.1780.9885.283.17
2113935-11393583.41084.34
3113796-11379683.30884.22
4116545-11654585.32086.27
5119608-11960887.56388.52
6118092-11809286.45387.38
120min1110230-11023080.69785.463.4481.7186.523.43
2115290-11529084.40285.47
3115342-11534284.44085.49
4120564-12056488.26389.35
5120934-12093488.53489.64
6118024-11802486.40387.48
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1111022-11102281.27785.803.4082.4387.013.39
2116139-11613985.02386.23
3114887-11488784.10785.30
4119107-11910787.19688.43
5121936-12193689.26790.52
6120124-12012487.94189.16
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%
116.014692358469250946923664690740468937646914700.03
215.994657602465266746551340.08
单位质量响应值RSD%判断
293033.73291127.830.47数据可信
供试品溶液-2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%
5min1340465-3404656.4916.536.336.496.536.34
2345087-3450876.5796.58
3359264-3592646.8506.85
4351494-3514946.7026.70
5357392-3573926.8146.81
6300624-3006245.7325.73
10min1636830-63683012.14212.124.8812.1512.134.88
2637824-63782412.16112.17
3661683-66168312.61612.63
4651164-65116412.41512.43
5650881-65088112.41012.42
6575313-57531310.96910.98
15min1865788-86578816.50716.425.0216.5416.465.02
2863110-86311016.45616.49
3900114-90011417.16217.19
4880341-88034116.78516.82
5881328-88132816.80316.84
6777465-77746514.82314.85
20min11048643-104864319.99319.905.1020.0519.965.10
21049289-104928920.00620.06
31084706-108470620.68120.74
41073198-107319820.46220.52
51068714-106871420.37620.44
6939245-93924517.90817.96
30min11345590-134559025.65525.375.5825.7525.465.59
21335841-133584125.46925.56
31386728-138672826.43926.53
41369649-136964926.11426.21
51361199-136119925.95326.05
61183363-118336322.56222.64
45min11687459-168745932.17331.565.8532.3131.705.85
21659939-165993931.64831.78
31726439-172643932.91633.06
41697744-169774432.36932.51
51698049-169804932.37532.51
61462670-146267027.88728.01
60min11946196-194619637.10636.346.0037.2936.536.00
21930500-193050036.80736.99
31987486-198748637.89338.09
41952682-195268237.23037.42
51943580-194358037.05637.25
61675916-167591631.95332.12
90min12334848-233484844.51643.745.6544.7743.985.65
22303622-230362243.92144.17
32384195-238419545.45745.71
42363731-236373145.06745.32
52342440-234244044.66144.91
62035587-203558738.81039.03
120min12613677-261367749.83249.166.2550.1649.486.24
22612363-261236349.80750.13
32678532-267853251.06951.40
42665421-266542150.81951.15
52646199-264619950.45250.78
62254541-225454142.98543.27
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12822578-282257853.81553.144.5354.2253.554.53
22814095-281409553.65454.06
32864303-286430354.61155.03
42845146-284514654.24654.66
52845518-284551854.25354.66
62532795-253279548.29048.65
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%
113.651167431168051167371166501166601167190.06
213.641166851167161167000.02
单位质量响应值RSD%判断
8550.848555.720.05数据可信
供试品溶液-3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%
5min1111782-11178282.51473.547.8182.5173.547.81
291548-9154867.57867.58
3103831-10383176.64576.65
493484-9348469.00769.01
594573-9457369.81169.81
6102559-10255975.70675.71
10min1124809-12480992.13183.207.5392.2783.337.53
2102020-10202075.30875.42
3116492-11649285.99186.12
4105650-10565077.98878.10
5109589-10958980.89681.01
6117739-11773986.91287.04
15min1128677-12867794.98685.418.0795.2885.668.07
2106319-10631978.48278.72
3120084-12008488.64388.91
4104663-10466377.25977.50
5113176-11317683.54383.79
6121276-12127689.52389.79
20min1129225-12922595.39087.056.7495.8487.466.74
2108337-10833779.97180.34
3121352-12135289.57990.00
4110921-11092181.87982.25
5114791-11479184.73685.13
6122941-12294190.75291.17
30min1130293-13029396.17988.966.8896.7989.516.88
2110679-11067981.70082.20
3123330-12333091.03991.61
4112795-11279583.26283.77
5117037-11703786.39486.93
6128937-12893795.17895.75
45min1131271-13127196.90189.776.1097.6790.466.12
2112718-11271883.20583.84
3124766-12476692.09992.82
4114569-11456984.57285.22
5118780-11878087.68088.36
6127540-12754094.14794.88
60min1133309-13330998.40590.696.2199.3491.546.22
2113562-11356283.82884.61
3125635-12563592.74093.61
4115760-11576085.45186.24
5120439-12043988.90589.73
6128431-12843194.80495.69
90min1134716-13471699.44492.006.00100.5493.006.01
2116173-11617385.75686.67
3127362-12736294.01595.04
4116921-11692186.30887.24
5122237-12223790.23291.20
6130372-13037296.23797.28
120min1134962-13496299.62592.735.90100.8993.885.92
2116536-11653686.02487.08
3128054-12805494.52695.71
4118553-11855387.51388.59
5123379-12337991.07592.20
6132248-13224897.62298.83
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1135629-135629100.11893.465.43101.5494.765.45
2118433-11843387.42488.63
3128609-12860994.93696.28
4119930-11993088.52989.75
5124527-12452791.92293.19
6132533-13253397.83299.20
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%
116.014698438470065546980614695168469362246971890.06
215.994683139468450846838240.03
单位质量响应值RSD%判断
293390.94292922.080.12数据可信
供试品溶液-3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%
5min1292032-2920325.5475.452.955.555.452.97
2275740-2757405.2385.24
3297822-2978225.6575.66
4292220-2922205.5515.55
5282275-2822755.3625.36
6280677-2806775.3325.33
10min1541461-54146110.28610.282.9810.2910.282.95
2518520-5185209.8509.86
3558306-55830610.60510.61
4560314-56031410.64410.65
5532155-53215510.10910.12
6534685-53468510.15710.17
15min1754836-75483614.33914.463.9914.3714.493.99
2727718-72771813.82413.85
3785195-78519514.91514.94
4809814-80981415.38315.41
5745008-74500814.15214.18
6745256-74525614.15714.18
20min1923004-92300417.53317.743.0617.5817.793.07
2905670-90567017.20417.25
3966424-96642418.35818.41
4972986-97298618.48318.54
5917985-91798517.43817.49
6916522-91652217.41017.46
30min11203926-120392622.87023.252.5522.9523.342.55
21188973-118897322.58622.66
31260932-126093223.95224.04
41263971-126397124.01024.09
51209220-120922022.97023.05
61218234-121823423.14123.22
45min11532237-153223729.10629.592.2129.2229.712.22
21524287-152428728.95529.07
31595948-159594830.31630.44
41605506-160550630.49830.62
51551156-155115629.46629.58
61538481-153848129.22529.34
60min11786739-178673933.94134.662.1934.1134.832.20
21793655-179365534.07234.23
31871131-187113135.54435.72
41877570-187757035.66635.84
51818776-181877634.54934.72
61800759-180075934.20734.37
90min12181968-218196841.44842.351.8241.6742.581.82
22212740-221274042.03342.25
32277992-227799243.27243.50
42281208-228120843.33343.57
52212463-221246342.02842.25
62210768-221076841.99542.22
120min12484764-248476447.20048.401.8547.4948.701.85
22520361-252036147.87648.17
32589392-258939249.18849.49
42614405-261440549.66349.97
52537783-253778348.20748.50
62541635-254163548.28048.57
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12690861-269086151.11552.321.7551.4952.691.75
22739719-273971952.04352.41
32784522-278452252.89453.28
42830679-283067953.77154.16
52747755-274775552.19652.57
62730780-273078051.87352.25
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%
113.651175551176341176431174911176431175930.06
213.641186631186311186470.02
单位质量响应值RSD%判断
8614.878698.460.69数据可信
供试品溶液-24070302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%
5min1100481-10048173.28869.503.2973.2969.503.29
293439-9343968.15268.15
395911-9591169.95569.95
494901-9490169.21869.22
595928-9592869.96769.97
691096-9109666.44366.44
10min1108389-10838979.05675.742.4479.1875.862.44
2102160-10216074.51374.63
3104263-10426376.04776.16
4103362-10336275.39075.50
5103896-10389675.77975.90
6100983-10098373.65473.77
15min1110250-11025080.41377.512.2480.6777.752.24
2105224-10522476.74876.99
3106875-10687577.95278.20
4105438-10543876.90477.14
5106688-10668877.81578.06
6103107-10310775.20475.44
20min1112088-11208881.75478.642.1682.1479.012.17
2106704-10670477.82778.19
3108020-10802078.78779.16
4107378-10737878.31978.69
5107634-10763478.50578.88
6105105-10510576.66177.02
30min1113440-11344082.74079.872.0283.2680.382.02
2108877-10887779.41279.91
3110032-11003280.25480.76
4108987-10898779.49279.99
5108987-10898779.49280.00
6106723-10672377.84178.33
45min1115536-11553684.26981.471.8784.9382.101.88
2110630-11063080.69181.32
3111914-11191481.62782.27
4111370-11137081.23081.86
5111411-11141181.26081.90
6109317-10931779.73380.35
60min1116112-11611284.68982.081.8185.4982.851.81
2112418-11241881.99582.76
3112934-11293482.37183.15
4112120-11212081.77782.54
5111701-11170181.47282.24
6109928-10992880.17980.93
90min1118324-11832486.30283.432.0787.2584.342.08
2113704-11370482.93383.83
3114988-11498883.86984.78
4114269-11426983.34584.25
5114011-11401183.15784.06
6110994-11099480.95681.84
120min1118871-11887186.70184.171.7187.7985.211.72
2115078-11507883.93584.97
3115999-11599984.60785.66
4114919-11491983.81984.86
5114529-11452983.53484.58
6112973-11297382.40083.42
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1119940-11994087.48184.901.6688.7186.091.66
2115972-11597284.58785.76
3116961-11696185.30886.50
4115651-11565184.35385.54
5115572-11557284.29585.48
6114344-11434483.40084.55
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%
116.014727046472691747297784727225473226247286460.05
215.994786524478529547859100.02
单位质量响应值RSD%判断
295355.78299306.440.94数据可信
供试品溶液-24070302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%
5min1311676-3116765.8385.696.855.845.696.81
2286974-2869745.3755.38
3306727-3067275.7455.74
4319247-3192475.9795.98
5326870-3268706.1226.12
6271584-2715845.0875.09
10min1597717-59771711.19510.674.6711.2010.684.66
2551263-55126310.32510.33
3585817-58581710.97210.98
4586402-58640210.98310.99
5571005-57100510.69510.71
6526563-5265639.8629.87
15min1822315-82231515.40214.844.6615.4314.864.67
2779074-77907414.59214.62
3816253-81625315.28815.32
4815235-81523515.26915.30
5795475-79547514.89914.93
6724292-72429213.56613.59
20min11016541-101654119.04018.264.6619.0918.314.65
2962168-96216818.02118.07
31002167-100216718.77118.82
41000603-100060318.74118.79
5976208-97620818.28418.34
6891269-89126916.69316.74
30min11314607-131460724.62323.805.2724.7123.885.27
21261227-126122723.62323.70
31341106-134110625.11925.20
41297052-129705224.29424.38
51261406-126140623.62623.71
61149761-114976121.53521.61
45min11662436-166243631.13730.064.9331.2630.184.93
21606286-160628630.08630.21
31653848-165384830.97631.10
41655183-165518331.00131.13
51599485-159948529.95830.08
61453463-145346327.22327.33
60min11939364-193936436.32435.095.0636.5035.265.05
21918035-191803535.92536.09
31929531-192953136.14036.32
41905683-190568335.69335.87
51860142-186014234.84035.01
61688796-168879631.63131.79
90min12346125-234612543.94342.465.2844.1842.695.27
22286343-228634342.82343.05
32352023-235202344.05344.29
42315477-231547743.36943.61
52269713-226971342.51242.74
62032020-203202038.06038.27
120min12664153-266415349.89948.144.8950.2148.444.90
22590597-259059748.52248.82
32655189-265518949.73250.04
42621462-262146249.10049.41
52562924-256292448.00348.30
62325638-232563843.55943.83
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12857366-285736653.51852.043.6953.9152.423.70
22805910-280591052.55552.94
32841937-284193753.22953.62
42819911-281991152.81753.21
52765339-276533951.79552.18
62579666-257966648.31748.66
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