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Detection method and application of polyhydric alcohol

A detection method and polyol technology, applied in the field of analysis and detection, can solve the problems of less quantitative research on diethylene glycol tripropylene glycol

Pending Publication Date: 2022-02-18
HEFEI JIUNUO MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, most studies focus on the quantification of propylene oxide in ornidazole injection, while there are few quantitative studies on diethylene glycol, dipropylene glycol and tripropylene glycol

Method used

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  • Detection method and application of polyhydric alcohol
  • Detection method and application of polyhydric alcohol
  • Detection method and application of polyhydric alcohol

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0073] Embodiment 1 (system suitability test)

[0074] A detection method for polyalcohols, comprising the steps of:

[0075] Detect with 7890A gas chromatograph, workstation is Open LAB chromatographic workstation (Agilent Technologies Co., Ltd.), and detector is FID detector, and chromatographic condition is:

[0076] The chromatographic column is an Agilent DB-WAX UI capillary column (30.0m×0.32mm, 0.25μm),

[0077] The carrier gas is high-purity nitrogen, the carrier gas flow rate is 3.0ml / min, the split ratio is 5:1, the inlet temperature is 220°C, the detector temperature is 250°C, the injection volume is 2μl, and the column temperature is raised according to the temperature program For detection, the specific heating program is as follows: the initial temperature is 120°C, the temperature is raised to 230°C at a speed of 10°C / min, and the temperature is kept for 25 minutes.

[0078] Solution preparation:

[0079] Blank solution (i.e. diluent): methanol solution of 1,...

Embodiment 2

[0090] Embodiment 2 (detection limit and quantitative limit)

[0091] The detection method is the same as in Example 1.

[0092] Solution preparation:

[0093] Weigh an appropriate amount of dipropylene glycol reference substance, diethylene glycol reference substance, and tripropylene glycol reference substance, and dilute them step by step with a blank solution to form a series of solutions with different concentrations, take 2 μl each, and detect them sequentially. The signal-to-noise ratio is approximately The injection concentration at 3 o'clock was used as the detection limit, and the injection concentration at about 10 when the signal-to-noise ratio was taken as the quantification limit. The detection limits of dipropylene glycol, diethylene glycol, and tripropylene glycol were measured to be 0.18, 0.15, and 0.45 μg / mL, respectively, and the quantification limits of dipropylene glycol, diethylene glycol, and tripropylene glycol were 0.60, 0.50 μg / mL, respectively. , 1...

Embodiment 3

[0094] Embodiment 3 (linear test)

[0095] The detection method is the same as in Example 1.

[0096] Solution configuration:

[0097] Accurately weigh the appropriate amount of dipropylene glycol reference substance, diethylene glycol reference substance, and tripropylene glycol reference substance, and dilute it with a blank solution to make about 5 mg of dipropylene glycol, 0.05 mg of diethylene glycol, and tripropylene glycol in each 1 ml. Propylene glycol 1.5mg linear stock solution; accurately measure 0.5ml of linear stock solution, put it in a 50ml measuring bottle, dilute to the mark with blank solution, shake well, and use it as linear No. 1 solution; precisely measure linear stock solution 0.5ml, 1ml, Put 2ml, 3ml, and 4ml into 20ml measuring bottles respectively, dilute to the mark with blank solution, shake well, and use it as linear solution No. 2-6. Precisely measure 2 μl each of the linear solutions No. 1-6, inject them into the gas chromatograph respectively,...

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Abstract

The invention discloses a detection method of polyhydric alcohol which comprises the following steps: preparing a test sample solution from a test sample by using a diluent, and detecting the test sample solution by using a gas chromatographic method under the chromatographic conditions that a capillary chromatographic column of polyethylene glycol is used as a stationary phase, the temperature of a sample inlet is 200-250 DEG C, the temperature of a detector is 220-350 DEG C, the column temperature is detected according to programmed temperature rise, wherein the specific temperature rise program is as follows: the initial temperature is 110-130 DEG C, the temperature is raised to 220-240 DEG C at the speed of 5-15 DEG C / min, and the temperature is kept for 0-30 min; the polyol is at least one of diethylene glycol, dipropylene glycol and tripropylene glycol. The method is simple to operate, good in separation degree, sensitive and efficient; and diethylene glycol, dipropylene glycol and tripropylene glycol can be detected. The method can be applied to detection of polyhydric alcohols in the ornidazole injection, and a reliable analysis method is provided for quality control analysis of the ornidazole injection.

Description

technical field [0001] The invention relates to the technical field of analysis and detection, in particular to a polyol detection method and its application. Background technique [0002] Polyhydric alcohols refer to alcohols containing two or more hydroxyl groups in the molecule, such as ethylene glycol, propylene glycol, glycerol, pentaerythritol, mannitol, sorbitol, etc., among which lower polyols, such as dihydric Alcohols (ethylene glycol, propylene glycol, diethylene glycol, dipropylene glycol, tripropylene glycol, etc.), due to their unique physical and chemical properties such as small molecular weight, relatively low viscosity, and relatively low boiling point, are widely used in the chemical industry and are deeply rooted in people The basic necessities of life have become the testing and monitoring objects of food and drug quality and safety assessment. [0003] At present, the analysis and research on polyols focus on the purity analysis and residual detection ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/06G01N30/68
CPCG01N30/06G01N30/68
Inventor 吴标李前进施伶俐崔红晓夏菊梅
Owner HEFEI JIUNUO MEDICAL TECH
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