A liquid chromatographic method for the determination of histamine in immunoglobulin preparation using solid phase extraction and pre-column derivatization.

A liquid chromatographic method for the determination of histamine in immunoglobulin preparation using solid phase extraction and pre-column derivatization. Research Abstract Details 

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A liquid chromatographic method for the determination of histamine in immunoglobulin preparation using solid phase extraction and pre-column derivatization. Abstract Text:

Nam Hee Kim,Youmie Park,Eun Sook Jeong,Chang-Soo Kim,Min Kyo Jeoung,Kyoung Soon Kim,Seung-Hwa Hong,Jong-Keun Son,Jin Tae Hong,Il-Young Park,Dong-Cheul Moon,Nam Hee Kim,Youmie Park,Eun Sook Jeong,Chang-Soo Kim,Min Kyo Jeoung,Kyoung Soon Kim,Seung-Hwa Hong,Jong-Keun Son,Jin Tae Hong,Il-Young Park,Dong-Cheul Moon,

An immunoglobulin (IgG) preparation with micro-amount of histamine fixed on the active protein fraction has been used to increase the resistance to allergic reactions. However, excessive histamine may cause hypo- or hypertension, headache, or anaphylactic shock and so the histamine content of the drug is strictly controlled by a regulation: 0.15 microg of histamine dihydrochloride is allowed for 12 mg of immunoglobulin. In this study, a liquid chromatographic method to determine micro-amount of histamine in the pharmaceutical was developed and validated. This method include a sample cleanup by a solid phase extraction (SPE) using a polystyrene-divinyl benzene (PS-DVB) polymeric sorbent and high-performance liquid chromatography after precolumn fluorescent labeling of the histamine with o-phthaldialdehyde. The drug sample was loaded to the SPE cartridge after adjusting to pH 9.5. After successive washings of the cartridge with water and 30% aqueous methanol, histamine was then eluted with 100 mM sodium acetate (pH 9.5)-methanol (20:80, v/v). An aliquot from the eluate was labeled with o-phthaldialdehyde-mercaptoethanol (OPA-ME) for fluorescence detection at the excitation maximum of 340 nm and emission maximum of 450 nm. HPLC analysis was performed on a phenyl-hexyl column with an acetonitrile-phosphate buffer (pH 6.8; 50 microM) (35:65, v/v) as the mobile phase. The retention times of histamine and 3-methylhistamine (IS) were approximately 7.2 and 9.5 min, respectively. The quantitation range was between 0.01-0.2 mg/mL of histamine showing good linearity (r=0.9996). This analytical method would provide a potential mean for the strict control of histamine content in the pharmaceutical product.

A liquid chromatographic method for the determination of histamine in immunoglobulin preparation using solid phase extraction and pre-column derivatization. Publishing Authors By Initials

NH Kim,Y Park,ES Jeong,CS Kim,MK Jeoung,KS Kim,SH Hong,JK Son,JT Hong,IY Park,DC Moon,NH Kim,Y Park,ES Jeong,CS Kim,MK Jeoung,KS Kim,SH Hong,JK Son,JT Hong,IY Park,DC Moon,

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A liquid chromatographic method for the determination of histamine in immunoglobulin preparation using solid phase extraction and pre-column derivatization. Journal Published:

PUBLICATION TYPE: Research Support, Non-U.S. Gov

Journal: Archives of pharmacal research

VOLUME: 30

Page Numbers: 1350-7

Journal Abbreviation: Arch. Pharm. Res.

ISSN: 0253-6269

DAY: 27

MONTH: Oct

YEAR: 2007

A liquid chromatographic method for the determination of histamine in immunoglobulin preparation using solid phase extraction and pre-column derivatization. Information

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LANGUAGE: eng

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Grant and Affiliation Information for A liquid chromatographic method for the determination of histamine in immunoglobulin preparation using solid phase extraction and pre-column derivatization.

AFFILIATION: College of Pharmacy CBITRC, Chungbuk National University, Cheongfu 361-763, Korea.

Country: Korea (South)

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MEDLINETA: Arch Pharm Res

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