Method for rapidly determining molecular weight, distribution and impurity content of polyethylene glycol derivative
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A polyethylene glycol, rapid determination technology, applied in the field of analysis and testing, can solve the problem of few molecular weight methods, and achieve the effect of fast analysis speed and high resolution
Active Publication Date: 2017-09-29
INST OF ANALYSIS GUANGDONG ACAD OF SCI (CHINA NAT ANALYTICAL
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[0005] The purpose of the present invention is to: overcome the problem that the method for measuring the molecular weight of PEG derivatives in the prior art is less, provide a kind of new method for measuring the molecular weight of polyethylene glycol derivatives and its distribution and impurity content
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Embodiment 1
[0032] The determination of the molecular weight, distribution and impurity content of monomethoxy polyethylene glycol propyl aldehyde (mPEG_pALD) includes the following steps:
[0033] 1.1 Solution preparation
[0034] Preparation of standard solution: Take 2.0 mg of polyethylene glycol (PEG) standard and the peak molecular weight (M p ) Respectively 2010Da, 3120Da, 6240Da, 8600Da, 12000Da, 23000Da, 40000Da, 230,000Da, 478000Da, add 1.5mL of methanol and water with a volume ratio of 95:5, leave it at room temperature for 24h, and wait until the standard is completely dissolved.
[0035] Preparation of sample solution: Weigh 50 mg of mPEG_pALD sample into a 10 mL volumetric flask, add methanol and water with a volume ratio of 95:5 to dissolve it to a constant volume, and wait for measurement.
[0049] The determination of the molecular weight, distribution and impurity content of Y-shape PEG-NH2 includes the following steps:
[0050] 2.1 Solution preparation
[0051] Preparation of standard solution: Take 2.0 mg of polyethylene glycol (PEG) standard and the peak molecular weight (M p ) Are 600Da, 1500Da, 2010Da, 3120Da, 6240Da, 8600Da, 12000Da, 23000Da, and 40000Da respectively. Add 1.5mL of methanol and water with a volume ratio of 90:10% and leave it at room temperature for 24h. After the standard is completely dissolved, it will be tested.
[0052] Preparation of sample solution: Weigh 40 mg of Y-type polyethylene glycol amine sample into a 10 mL volumetric flask, add methanol and water with a volume ratio of 90:10 to dissolve to a constant volume, and wait for measurement.
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Abstract
The invention discloses a method for rapidly determining the molecular weight, distribution and impurity content of a polyethylene glycol derivative. According to the method, an ACQUITY APC XT series super-efficient gel column is adopted, methanol is taken as a mobile phase, the molecular weight and distribution of the polyethylene glycol derivative are determined through differential refraction, and the molecular weight of the polyethylene glycol derivative is obtained; and a principal component and relative content of impurities of the polyethylene glycol derivative are obtained by virtue of an area normalization method. The method disclosed by the invention has the advantages of high resolution ratio and high analysis speed, the molecular weight and distribution of the polyethylene glycol derivative can be rapidly determined within the shortest time of 5.3 minutes, and the impurities in the polyethylene glycol derivative can be effectively separated, so that the purity of the principal component and the content of the impurities are obtained. The invention provides a new determination method for process research and development and quality control, and the method provided by the invention has good application prospects.
Description
Technical field [0001] The invention belongs to the technical field of analysis and testing. More specifically, the invention relates to a gel permeation chromatography (GPC) method for measuring polymer molecular weight. Background technique [0002] Polyethylene glycol (PEG) derivatives are widely used in cosmetics, pharmaceuticals, chemical, food processing and other industries, and their molecular weight and purity have a great impact on the performance of the product. For example, as a modifier of protein drugs, polyethylene glycol derivatives can modify protein drugs and improve the disadvantages of protein drugs that are easily hydrolyzed by enzymes, short circulating half-life, high immunogenicity and low solubility, and can also be used for modification Other drugs improve their performance (increase water solubility, extend half-life, etc.), and their molecular weight, distribution and impurity content have a greater impact on the efficacy of the modified drug. Therefo...
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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/06G01N30/60G01N30/74
CPCG01N30/06G01N30/6039G01N30/74
Inventor 黄晓兰吴惠勤谢梦婷罗辉泰黄芳林晓珊朱志鑫
Owner INST OF ANALYSIS GUANGDONG ACAD OF SCI (CHINA NAT ANALYTICAL
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