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Detecting method for 5-hydroxymethylfurfural in peritoneal dialysis solution

A technology for peritoneal dialysis fluid and hydroxymethyl furfural, applied in the field of medicine, can solve the problems of low accuracy, difficult quality control of peritoneal dialysis fluid, etc., and achieve the effects of improving product quality and safety and optimizing process

Inactive Publication Date: 2017-03-29
HUAREN PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

5-Hydroxymethylfurfural has a maximum absorbance at 284nm, and can be detected by ultraviolet spectrophotometry. In the national quality standard for peritoneal dialysate (lactate), UV spectrophotometer is used to measure 5-Hydroxymethylfurfural. This method Not very accurate
[0003] At present, in the field of drug detection technology, there is a lack of methods that can easily, quickly and accurately detect the content of 5-hydroxymethylfurfural in peritoneal dialysis fluid, and it is difficult to accurately control the quality of peritoneal dialysis fluid

Method used

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  • Detecting method for 5-hydroxymethylfurfural in peritoneal dialysis solution
  • Detecting method for 5-hydroxymethylfurfural in peritoneal dialysis solution
  • Detecting method for 5-hydroxymethylfurfural in peritoneal dialysis solution

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Embodiment 1

[0016] The detection method of 5-hydroxymethylfurfural in the peritoneal dialysate of the present embodiment comprises the following steps:

[0017] Step 1: Prepare the reference solution

[0018] Accurately weigh 5-hydroxymethylfurfural reference substance, add water to dissolve to make 0.9 μg / ml 5-hydroxymethylfurfural aqueous solution;

[0019] Step 2: Prepare the test solution

[0020] Take an appropriate amount of peritoneal dialysis fluid and place it in a 50ml volumetric bottle, dilute to the mark with water; among them, accurately measure 9.2ml of peritoneal dialysis fluid with a glucose concentration of 1.5%, and precisely measure 5.5ml of peritoneal dialysis fluid with a glucose concentration of 2.5%. Precisely measure 3.2ml of peritoneal dialysate with a concentration of 4.25%;

[0021] Step 3: Detection by HPLC

[0022] Extract 20 μl each of the control solution and the test solution, inject them into the chromatograph, record the chromatogram, and calculate the...

Embodiment 2

[0025] The detection method of 5-hydroxymethylfurfural in the peritoneal dialysate of the present embodiment is the same as Example 1 except for the following differences:

[0026] The chromatographic conditions in step 3 are: adopt C18 chromatographic column, acetonitrile-water (3:97V / V) is mobile phase, flow velocity: 0.8ml / min, column temperature: 25 ℃, detection wavelength: 289nm, the number of theoretical plate is according to 5- HMF peak calculation, the number of theoretical plates is greater than or equal to 1000. Example 3

Embodiment 3

[0027] The detection method of 5-hydroxymethylfurfural in the peritoneal dialysate of the present embodiment is the same as Example 1 except for the following differences:

[0028] The chromatographic conditions in step 3 are: adopt C18 chromatographic column, acetonitrile-water (5:95V / V) is mobile phase, flow velocity: 1.2ml / min, column temperature: 35 ℃, detection wavelength: 279nm, the number of theoretical plate is according to 5- HMF peak calculation, the number of theoretical plates is greater than or equal to 1000.

[0029] Carry out methodological verification to the method of the present embodiment:

[0030] (1) Maximum absorption wavelength

[0031] Take 5-hydroxymethylfurfural reference substance, weigh it accurately, add water to dissolve it to make a 0.9 μg / ml solution, and use a UV-visible spectrophotometer to scan in the wavelength range of 200-800nm, and the maximum absorption wavelength is 284nm;

[0032] (2) Specificity

[0033] Take the blank solution, mo...

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Abstract

The invention belongs to the field of medical technologies and relates to a detecting method for 5-hydroxymethylfurfural in a peritoneal dialysis solution. A 5-hydroxymethylfurfural comparison product is precisely weighed and dissolved with water, a comparison product solution is prepared, an appropriate quantity of peritoneal dialysis solution is taken to be put into a measuring bottle and diluted with water to a scale, a solution for a testing product is prepared, 20 microliters of comparison fluid and 20 microliters of fluid for testing are precisely taken and injected into a chromatographic instrument, a chromatogram map is recorded, and the labeled amount of 5-hydroxymethylfurfural in the peritoneal dialysis solution is obtained according to an external standard method through peak area calculation; through efficient liquid chromatography, the content of 5-hydroxymethylfurfural in the peritoneal dialysis solution is accurately detected, accurate control over the quality of the peritoneal dialysis solution is achieved, the technology is easily optimized, and product quality and safety are improved.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to a method for detecting 5-hydroxymethylfurfural in peritoneal dialysis fluid. Background technique [0002] Peritoneal dialysis solution is a clear, sterile, pyrogen-free and endotoxin-free solution with a suitable pH value prepared by sodium, potassium, calcium, magnesium, chlorine, buffer substances and glucose. Clinically, it can be used to treat acute or chronic renal failure, drug poisoning, refractory heart failure, severe electrolyte disturbance, such as hyperkalemia, etc. The amount of glucose degradation product 5-hydroxymethylfurfural in the finished product is one of the reasons to investigate the stability of the dialysate. 5-Hydroxymethylfurfural is an aldehyde compound produced by the dehydration of monosaccharide compounds such as glucose under high temperature or weak acid conditions. This compound is harmful to human striated muscles and internal organs. 5-Hydr...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
Inventor 陈红妍刘春霞
Owner HUAREN PHARMACEUTICAL CO LTD
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