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Method for determining residual amount of DMAP (dimethylaminopyridine) in pneumococcal polysaccharide-protein conjugate vaccine by adopting high performance liquid chromatography

A pneumococcal polysaccharide and high-performance liquid chromatography technology, which is applied in the direction of measuring devices, vector-borne diseases, and instruments, can solve the problems of high detection cost, inability to achieve solvent peak separation, and cumbersome methods, and achieve good repeatability, Eliminate interference from solvents and impurities, and achieve high accuracy

Pending Publication Date: 2022-05-27
BRAVOVAX
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  • Application Information

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Problems solved by technology

[0010] At present, there are few related studies on DMAP detection. There have been reports that GC-MS and HPLC methods are used for detection. Among them, GC-MS method has high sensitivity, but the method is cumbersome and the detection cost is high; HPLC method is easy to operate and specific. Strong, low detection cost, etc., but DMAP is a strong polar basic compound, which has no retention on conventional reversed-phase chromatography and cannot be separated from the solvent peak

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  • Method for determining residual amount of DMAP (dimethylaminopyridine) in pneumococcal polysaccharide-protein conjugate vaccine by adopting high performance liquid chromatography
  • Method for determining residual amount of DMAP (dimethylaminopyridine) in pneumococcal polysaccharide-protein conjugate vaccine by adopting high performance liquid chromatography
  • Method for determining residual amount of DMAP (dimethylaminopyridine) in pneumococcal polysaccharide-protein conjugate vaccine by adopting high performance liquid chromatography

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Embodiment Construction

[0026] The method for determining the residual amount of DMAP in a pneumococcal polysaccharide-protein conjugate vaccine by high performance liquid chromatography provided by the present invention will be further described in detail and completely below with reference to the examples. The embodiments described below are exemplary, only for explaining the present invention, and should not be construed as limiting the present invention.

[0027] The experimental methods in the following examples are conventional methods unless otherwise specified. The experimental materials used in the following examples were purchased from the market unless otherwise specified.

[0028] 1 Instruments and reagents

[0029] High performance liquid chromatograph with diode array detector (1260, Agilent), Sepax HP-C18 (5μm, 4.6×250mm, Suzhou Saifen), 1 / 100,000 electronic balance (MS105DU, METTLER TOLEDO) , pH meter (FE20, METTLER TOLEDO), centrifuge (X1R, Thermo Fisher Scientific).

[0030] DMAP...

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Abstract

The invention discloses a method for determining the residual amount of DMAP in a pneumococcal polysaccharide-protein conjugate vaccine by adopting a high performance liquid chromatography, the detection method adopts the high performance liquid chromatography to detect the residual amount of DMAP in the pneumococcal polysaccharide-protein conjugate vaccine, a mobile phase is a mixed solution of a 5 mmol / L sodium heptanesulfonate solution and acetonitrile, and the mobile phase is an acetonitrile solution. The chromatographic column is a C18 chromatographic column. According to the method for determining the residual amount of the DMAP in the pneumococcal polysaccharide-protein conjugate vaccine by adopting the high performance liquid chromatography, the method for determining the residual amount of the DMAP in the pneumococcal polysaccharide-protein conjugate vaccine by adopting the high performance liquid chromatography adopts reversed-phase ion pair chromatography, and the retention of the DMAP on a chromatographic column is realized through optimized chromatographic conditions; the method provided by the invention has the advantages of high accuracy and good repeatability, eliminates the interference of solvents and impurities, and has a good result when being used for measuring the residual amount of DMAP in the pneumococcus-protein conjugate vaccine.

Description

technical field [0001] The invention relates to a method for determining the residual amount of DMAP in a pneumococcal polysaccharide-protein conjugate vaccine by high performance liquid chromatography, and belongs to the field of downstream production of vaccines. Background technique [0002] Pneumococcus is the main pathogen of pneumonia, meningitis, otitis media and sinusitis, and also an important cause of morbidity and mortality in infants and the elderly. Bacterial capsular polysaccharide vaccine has a good effect in preventing invasive diseases caused by pneumococcus, meningococcus, Haemophilus influenzae, etc., but pneumococcal capsular polysaccharide is a non-T cell-dependent antigen, and the immunity of infants and young children The system is not fully developed, and polysaccharide antigens cannot produce an effective immune response to infants under the age of two, while polysaccharide-protein conjugate vaccines can convert T-cell-independent antigens into T-cel...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/8831G01N2030/8836Y02A50/30
Inventor 向海
Owner BRAVOVAX
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