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Method for detecting content of polyethylene glycol lipid and lipid nanoparticles containing same
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A polyethylene glycol lipid and lipid nanoparticle technology, applied in the field of chemical analysis, can solve the problems of weak polarity, undetectable, difficult elution, etc.
Active Publication Date: 2022-07-22
JENKEM TECH CO LTD TIANJIN
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However, in the prior art, there is no suitable detection method for the above-mentioned polymers
[0006]
M-DMG is a weakly polar Oita compound, which is difficult to elute on the C18 chromatographic column, and some known and unknown impurities mixed with this compound are even more difficult to elute
Therefore, in the reversed-phase chromatography with C18 chromatographic column as the main detection method, the substance is not easy to be detected and separated; since the substance has no ultraviolet absorption, it cannot be detected by a selective detector ultraviolet detector
There is no report on the specific assay method for polymer M-DMG at present, therefore, the specific assay method for polymer M-DMG is established for the detection of polyethylene glycol lipids, lipid nanoparticles, nucleic acid pharmaceutical compositions and preparations thereof important in quality control
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[0136] 100% test solution: Accurately weigh 20 mg of M-DMG-2000 to be tested and put it in a 10 mL volumetric flask, add acetonitrile to dissolve it, and shake it to a constant volume as the test solu...
Embodiment 2
[0154] The purity of the samples was calculated by the self-control method, and the linearity was verified for both high and low concentrations.
[0155] Preparation of reference stock solution and reference solution:
[0157] Accurately weigh about 20 mg of M-DMG-2000, put it in a 10 mL volumetric flask, add acetonitrile to dissolve, make up to the mark, and shake well.
[0161] Precisely measure 5mL of reference substance stock solution 2, put it in a 10mL volumetric flask, add diluent to make up to the mark, and shake well.
[0163] Precisely measure 5mL of reference solution 1, put it in ...
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technical field [0001] The invention relates to the technical field of chemical analysis, in particular to a method for detecting lipid nanoparticles by high performance liquid chromatographytandem mass spectrometry technology. Background technique [0002] The core principle of mRNA vaccines is to encode antigenic genetic information in mRNA, which is then delivered to the cytoplasm of host cells, where it is expressed in vivo and induces antigen-specific immune responses. One of the challenges encountered in developing mRNA vaccines is their poor stability, due to the fact that the single-stranded structure of the mRNA itself makes it extremely unstable and easily degraded, and it carries a negative charge and is delivered across the cell membrane, which is also negatively charged on the surface. It is also a difficult problem, so a special modification or packagedelivery system is required to achieve the intracellular expression of mRNA, change the biodistribution, cell...
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