Detection method for polyethylene glycol content

A polyethylene glycol and detection method technology, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve problems such as the inability to obtain the absolute content of polyethylene glycol intuitively, interfere with the peak of polyethylene glycol, and affect the quantitative results , to achieve low detection limit, prolong elution time and optimize chromatographic conditions

Active Publication Date: 2016-05-04
LIFETECH SCIENTIFIC (SHENZHEN) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because polyethylene glycol contains more hydroxyl groups and oxygen lone pair electrons, it has greater polarity, stronger hydrophilicity, and is easy to form hydrogen bonds. Its affinity with chromatographic column packing is very weak, and it was first used Eluted out, and the moisture and other solvents in the sample, as well as the solvent used for elution wil...

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  • Detection method for polyethylene glycol content
  • Detection method for polyethylene glycol content
  • Detection method for polyethylene glycol content

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Determination of the chromatogram of polyethylene glycol standard substance, which is purchased from SIGMA-ALDRICH, USA, has a molecular weight of 1000 and a dispersity of 1.02.

[0045] Chromatographic equipment: Elite EC2000 liquid chromatograph and SHODEXRI-201H differential refractive index detector, Elite P230 high-pressure constant-flow pump, ZW column thermostat, EC2000 chromatography data workstation;

[0046] Chromatographic column: a reversed-phase silica gel-bonded chromatographic column named ZenixSEC (Saifen Technology Co., Ltd., USA), with a specification of 3 μm 7.8mm×300mm;

[0047] Mobile phase: acetonitrile: chromatographically pure; pure water: the purity reaches at least the first grade specified in ISO3696; trifluoroacetic acid, chromatographically pure, with a purity >99.9%.

[0048] (1) Preparation of mobile phase: Accurately measure acetonitrile and purified water with a volume ratio of 40:60 and mix them evenly, add trifluoroacetic acid accord...

Embodiment 2

[0059] The sample to be tested is a balloon catheter with a drug coating. The drug coating contains paclitaxel and adjuvant with therapeutic effect. The adjuvant contains a certain amount of polyethylene glycol with a molecular weight of 1000. The degree of dispersion is the same as in Example 1. Similar to polyethylene glycol standard substance.

[0060] Chromatographic equipment: Elite EC2000 liquid chromatograph and SHODEXRI-201H differential refractive index detector, Elite P230 high-pressure constant-flow pump, ZW column thermostat, EC2000 chromatography data workstation

[0061] Chromatographic column: a reversed-phase silica gel-bonded chromatographic column named ZenixSEC (Saifen Technology Co., Ltd., USA), with a specification of 3 μm 7.8mm×300mm;

[0062] Mobile phase: acetonitrile: chromatographically pure; pure water: the purity reaches at least the first grade specified in ISO3696; trifluoroacetic acid chromatographically pure, with a purity >99.9%.

[0063] (1...

Embodiment 3

[0076] The sample to be tested is a balloon catheter with a drug coating. The drug coating contains the drug paclitaxel and auxiliary materials with therapeutic effects. The auxiliary materials contain a certain amount of polyethylene glycol with a molecular weight of 1000. The degree of dispersion is the same as that of Example 1. Similar to polyethylene glycol standard substance.

[0077] Use this invention to detect the specific content of polyethylene glycol after production and storage of samples, and the content is expressed in absolute amounts. This method is also used for polyethylene glycol incoming inspection, drug balloon catheter factory inspection, and stability test quality control Sample method.

[0078] Chromatographic equipment: Elite EC2000 liquid chromatograph and SHODEXRI-201H differential refractive index detector, Elite P230 high-pressure constant-flow pump, ZW column thermostat, EC2000 chromatography data workstation.

[0079] Chromatographic column: a ...

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Abstract

The invention discloses a detection method for polyethylene glycol content. The detection method utilizes the differences among the hydromechanical volumes of all components in a sample and, by optimizing chromatographic conditions, chooses a size exclusion chromatography column with appropriate grain size and aperture of chromatographic column packing to carry out high-quality separation, the chromatographic peak of polyethylene glycol is identified by a conventional common detector for laboratories, regression is carried out by an external standard method, and the absolute content of the polyethylene glycol in the sample is then quantified. The detection method disclosed by the invention solves the limitation in conventional methods, such as poor separation degree, low trace content test accuracy and test results only being capable of being expressed by percentage content, and the detection method is particularly suitable for detecting polyethylene glycol content or polyethylene glycol residue quantity in drugs or drug-carrying medical equipment, food, health-care products and other biological products.

Description

technical field [0001] The invention belongs to the field of content determination methods of pharmaceutical preparations, and relates to a method for analyzing drug coatings of drug-loaded medical devices, in particular to a method for detecting polyethylene glycol content. Background technique [0002] Polyethylene glycol (abbreviation: PEG) is formed by polycondensation of ethylene oxide and water, and its molecular formula is HO(CH 2 CH 2 O) n H, n represents the average number of oxyethylene groups, and its CAS registration number is 25322-68-3, which is white waxy solid flakes or granular powder with a slightly special odor. Polyethylene glycol is soluble in water, ethanol and many organic solvents, insoluble in ether, stable to heat, acid and alkali, and ineffective with many chemicals. [0003] Polyethylene glycol is non-toxic, non-irritating, and low in immunogenicity. It has good biocompatibility, can be excreted through the kidneys, and will not accumulate in t...

Claims

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Application Information

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IPC IPC(8): G01N30/74G01N30/60G01N30/86
CPCG01N30/60G01N30/74G01N30/8634
Inventor 宋精忠
Owner LIFETECH SCIENTIFIC (SHENZHEN) CO LTD
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