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
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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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