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High performance liquid chromatography analysis method of mifamurtide

A high-performance liquid chromatography and lumber peptide technology, which is applied in the analysis of materials, material separation, measurement devices, etc., can solve problems such as poor peak shape symmetry

Inactive Publication Date: 2014-07-16
深圳万乐药业有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Journal ofChromatography B, 2001 (754), 127-133 report adopts reversed-phase high performance liquid chromatography to analyze phosphatidylethanolamine, adopts triethylsilane chemically bonded silica gel to be the reversed-phase chromatographic column (C1) of stationary phase, and the mobile phase that adopts is Chloroform: methanol: water (1:33:6), but the peak shape is not symmetrical

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  • High performance liquid chromatography analysis method of mifamurtide
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  • High performance liquid chromatography analysis method of mifamurtide

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Embodiment Construction

[0018] 1. Instruments and reagents

[0019] 1.1 Instruments and reagents

[0020] Instrument: Agilent1200 high performance liquid chromatograph,

[0021] Waters UPLC-TOF / MS (LCT Premier XE)

[0022] Reagents: ammonium formate, methanol (analytical grade), pure water

[0023] Sample: Rice cutting peptide, self-made (Shenzhen Wanle Pharmaceutical Co., Ltd.)

[0024] 1.2 Chromatographic conditions

[0025] Chromatographic column: Ultimate LP-C18 (4.6mm×250mm, 5μm)

[0026] Detector: ELSD (drift tube temperature is 40°C, carrier gas pressure is 3.5psi, Gain is 6)

[0027] Mobile phase: mobile phase A is methanol, mobile phase B is water (5mM ammonium formate buffer salt, pH=7.0)

[0028] Using isocratic elution, mobile phase A: mobile phase B = 80:20

[0029] Flow rate: 1ml / min

[0030] Injection volume: 5μl

[0031] Column temperature: 30°C

[0032] Diluent: dichloromethane

[0033] 2. Solution Preparation

[0034] The test solution: Accurately weigh about 25mg of the...

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Abstract

The invention provides a high-performance liquid chromatography analysis method for michalum peptide. The method adopts a reversed-phase high-performance liquid chromatography and an evaporative light scattering detector to carry out isocratic elution on the sample, avoiding the use of normal instruments that are easily damaged. Phase chromatography, the elution procedure is simple, the peak shape is good, the separation between the main peak and the impurity peak is good, it can scientifically and conveniently control the purity and content of Mivawood peptide, and provide a simple and effective method for the quality control of the drug production process. Methods.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a high performance liquid chromatographic analysis method for mivawood peptide. Background technique [0002] Miphatide is a liposome-encapsulated cell wall tripeptide phosphotylethanolamine, which is a chemically synthesized dipeptide derivative. This product was researched and developed by Ciba-Geigy (now Novartis) in the 1980s. In 2003, IDM Pharma acquired the product and conducted clinical research. [0003] Miphatide is a mycobacterium cell wall component and a natural immune stimulant. This product is made into spherical liposomes, and the vesicles are muramyl tripeptide (MTP). This lipid triggers macrophages to consume mivaligin. Once depleted, MTP stimulates macrophages, especially in the liver, spleen and lungs, to seek out and kill tumor cells. In March 2009, IDM Pharma's Mifamurtide (L-MTP-PE, Mepact) was approved in Europe for the treatment of non-metastatic resectable oste...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/74G01N30/02
Inventor 李萍张广明钱建彬柏江涛
Owner 深圳万乐药业有限公司