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小木虫论坛-学术科研互动平台 » 生物医药区 » 新药研发 » 质量控制 » 硫酸沙丁胺醇美国药典检测方法
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lyf1023aaa

新虫 (初入文坛)

[交流] 硫酸沙丁胺醇美国药典检测方法 已有2人参与

各位大侠，哪位知道美国药典36,37版本中沙丁胺醇有关物质的检测色谱条件，跪求，谢了。。。。
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1楼 2014-07-31 08:07:14
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dingjinglvde

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Assay—
0.05 ± 0.01 M Ammonium acetate solution— Dissolve 3.85 g of ammonium acetate in 1000 mL of water, and mix.
Mobile phase— Prepare a degassed mixture of water, 0.05 ± 0.01 M Ammonium acetate solution, and isopropanol [65: 30: (5 ± 1)], and adjust dropwise with acetic acid to a pH of 4.5 ± 0.3.
Resolution solution— Dissolve accurately weighed quantities of USP Albuterol Sulfate RS and USP Albuterol Related Compound A RS in water, and dilute quantitatively, and stepwise if necessary, with Mobile phase to obtain a solution having a known concentration of about 0.140 mg per mL and 0.030 mg per mL, respectively.
Standard preparation— Dissolve an accurately weighed quantity of USP Albuterol Sulfate RS in water, and dilute quantitatively with water to obtain a solution having a known concentration of about 0.6 mg per mL.
Assay preparation— Transfer about 60 mg of Albuterol Sulfate, accurately weighed, to a 100-mL volumetric flask, dissolve in and dilute with water to volume, and mix.
Chromatographic system (see Chromatography 621)— The liquid chromatograph is equipped with a 276-nm detector and a 4.6-mm × 20-cm column that contains packing L10. The flow rate is about 2.0 mL per minute. Chromatograph the Resolution solution, and record the peak responses as directed for Procedure: the resolution, R, between albuterol and albuterol related compound A is not less than 1.5; and the relative standard deviation for replicate injections is not more than 1.5%.
Procedure— Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of (C13H21NO3)2·H2SO4 in the portion of Albuterol Sulfate taken by the formula:
100C(rU / rS)
in which C is the concentration, in mg per mL, of USP Albuterol Sulfate RS in the Standard preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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4楼2014-08-01 11:02:55
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lyf1023aaa

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引用回帖:
2楼: Originally posted by fkghsdkl at 2014-07-31 13:37:24
35的要不？？

可以啊，谢了哈。。。。
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3楼2014-08-01 08:33:25
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lyf1023aaa

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:victory：可不可以把美国35版的沙丁胺醇含量及有关物质检测的高效液相条件一起给一下啊？不胜感激。。
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5楼2014-08-01 15:33:34
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dingjinglvde

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引用回帖:
5楼: Originally posted by lyf1023aaa at 2014-08-01 15:33:34
:victory：可不可以把美国35版的沙丁胺醇含量及有关物质检测的高效液相条件一起给一下啊？不胜感激。。

USP35
Assay—
0.05 ± 0.01 M Ammonium acetate solution—Dissolve 3.85 g
of ammonium acetate in 1000 mL of water, and mix.
Mobile phase—Prepare a degassed mixture of water,  0.05 ±
0.01 M Ammonium acetate solution, and isopropanol [65: 30:
(5 ± 1)], and adjust dropwise with acetic acid to a pH of 4.5  ±
0.3.
Resolution solution—Dissolve accurately weighed quantities of
USP Albuterol Sulfate RS and  USP Albuterol Related Compound
A RS in water, and dilute quantitatively, and stepwise if neces-
sary, with Mobile phase to obtain a solution having a known
concentration of about 0.140 mg per mL and 0.030 mg per
mL, respectively.
Standard preparation—Dissolve an accurately weighed quan-
tity of USP Albuterol Sulfate RS in water, and dilute quantita-
tively with water to obtain a solution having a known concen-
tration of about 0.6 mg per mL.
Assay preparation—Transfer about 60 mg of Albuterol Sul-
fate, accurately weighed, to a 100-mL volumetric flask, dissolve
in and dilute with water to volume, and mix.
Chromatographic system (see Chromatography 〈621〉—The
liquid chromatograph is equipped with a 276-nm detector and
a 4.6-mm × 20-cm column that contains packing L10. The flow
rate is about 2.0 mL per minute. Chromatograph the  Resolution
solution, and record the peak responses as directed for  Proce-
dure: the resolution,  R, between albuterol  and albuterol related
compound A is not less than 1.5; and the relative standard
deviation for replicate injections is not more than 1.5%.
Procedure—Separately inject equal volumes (about 10  µL) of
the Standard preparation and the  Assay preparation into the
chromatograph, record the chromatograms, and measure the
responses for the major peaks. Calculate the quantity, in mg, of
(C13H21NO3)2 · H2SO4 in the portion of Albuterol Sulfate taken by
the formula:
100C(rU / rS)
in which C is the concentration, in mg per mL, of USP Albuterol
Sulfate RS in the  Standard preparation; and  rU and  rS are the
peak responses obtained from the  Assay preparation and the
Standard preparation, respectively.
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6楼2014-08-01 16:27:58
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