A kind of detection method of polyethylene glycol content
A technology of polyethylene glycol and detection method, which is applied to measurement devices, instruments, scientific instruments, etc., can solve the problems of inability to intuitively obtain the absolute content of polyethylene glycol, interfere with the peak output of polyethylene glycol, and affect quantitative results. , to achieve the effect of low detection limit, prolonged elution time, and optimized 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 SHODEX RI-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 Zenix SEC (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 ISO 3696; trifluoroacetic acid, chromatographically pure, with a purity of >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 ...
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. The standard substance of polyethylene glycol is similar.
[0060] Chromatography equipment: Elite EC2000 liquid chromatograph and SHODEX RI-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 Zenix SEC (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 ISO 3696; trifluoroacetic acid chromatographically pure, with a purity >99.9%.
...
Embodiment 3
[0076] 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. The standard substance of polyethylene glycol is similar.
[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 delivery inspection, and stability test quality control Sample method.
[0078] Chromatographic equipment: Elite EC2000 liquid chromatograph and SHODEX RI-201H differential refractive index detector, Elite P230 high-pressure constant-flow pump, ZW column thermostat, EC2000 chromatography data workstation.
[0079] Chromatographic column: a reversed-phase silica gel b...
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