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Method for detecting vitamin B12-related substances in multivitamin preparation

A technology for vitamin preparations and related substances, which is applied in the field of detection of vitamin B2 related substances in multivitamin preparations, and can solve the problems of small disinfection loss and easy damage

Inactive Publication Date: 2018-03-30
济南维瑞医药科技开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Vitamin B 12 It is a light red needle-like crystal, easily soluble in water and ethanol, most stable under weak acid conditions with a pH value of 4.5-5.0, decomposed in strong acids (pH<2) or alkaline solutions, and can be destroyed to a certain extent when heated, but short-term The loss of high temperature disinfection time is small, and it is easily destroyed by strong light or ultraviolet rays

Method used

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  • Method for detecting vitamin B12-related substances in multivitamin preparation
  • Method for detecting vitamin B12-related substances in multivitamin preparation
  • Method for detecting vitamin B12-related substances in multivitamin preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] 1. Chromatographic conditions

[0024] Instrument: high performance liquid chromatography;

[0025] Column: AQ-C 18 Column (Model: Ultimate, 250×4.6mm, 5μm);

[0026] Mobile phase A: disodium hydrogen phosphate solution, mobile phase B: methanol;

[0027] Detection wavelength: 361nm;

[0028] Column temperature: 30°C;

[0029] Flow rate: 1.0ml / min;

[0030] Running time: about 160 minutes;

[0031] Injection volume: 500μl

[0032] Carry out gradient elution according to the following table:

[0033]

[0034]

[0035] 2. Sample preparation

[0036] (1) Preparation of mobile phase

[0037] Mobile phase A: prepare 0.025 mol / L disodium hydrogen phosphate solution (adjust the pH to 3.5 with phosphoric acid); mobile phase B: methanol.

[0038] (2) preparation of test solution

[0039] Avoid light operation. Take an appropriate amount of the contents of this product (approximately equivalent to vitamin B 12 45 μg), accurately weighed, put in a separatory fun...

Embodiment 2

[0047] Solvent: water.

[0048] Need testing solution: prepare with " need testing solution preparation " method in embodiment 1.

[0049] Negative sample solution: prepared with the method of "preparation of test sample solution" in Example 1.

[0050] Raw material solution: take vitamin B 12 Appropriate amount of raw materials, accurately weighed, dissolved in water and diluted to make each 1ml contains about vitamin

[0051] Prime B 12 1.8 μg of the solution, shake well, filter, that is.

[0052] Precisely measure 500 μl of each of the above solutions, inject them into the liquid chromatograph, and record the chromatograms. See the attached manual for the diagram Figure 4 .

[0053] The results showed: Negative samples and solvents for vitamin B 12 And its impurity peaks have no interference, tailing factor, theoretical plate number

[0054] According to the regulations, the separation is good, indicating that the system suitability test results are good.

Embodiment 3

[0056] Instrument: high performance liquid chromatography;

[0057] Column: AQ-C 18 Column (Model: Ultimate, 250×4.6mm, 5μm);

[0058] Mobile phase A: disodium hydrogen phosphate solution, mobile phase B: methanol;

[0059] Detection wavelength: 355nm;

[0060] Column temperature: 35°C;

[0061]Flow rate: 1.2ml / min;

[0062] Running time: about 160 minutes;

[0063] Injection volume: 500μl

[0064] Carry out gradient elution according to the following table:

[0065] time (minutes)

[0066] Need testing solution preparation method is carried out according to the method of " need testing solution preparation " in embodiment 1, and measurement collection of illustrations is shown in the accompanying drawings Figure 5 .

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Abstract

The invention discloses a method for detecting vitamin B12-related substances in a multivitamin preparation. The method comprises the following steps: performing gradient eluting by taking a sodium dihydrogen phosphate solution as a flowing phase A and taking methyl alcohol as a flowing phase B under the chromatographic condition that octadecylsilane chemically-bonded silica is taken as a chromatographic column filling agent, wherein the detecting wavelength is 300 to 400 nm, the column temperature is 20 to 50 DEG C, the flowing speed is 0.5 to 2.0 mL / min, the sample inlet amount is 300 to 700mu l, and the running time is 100 to 200 minutes; preparing a sample solution, namely, preparing a sample solution for a test by adopting an extracting method, wherein the concentration can be 0.5 to100 mu g / ml, taking another sample solution for the test, and diluting the sample solution to the test 50 times to serve as a control solution; determining, namely, injecting the solution into a highperformance liquid chromatograph, recording a chromatogram, and analyzing. The method is simple, high-efficiency, high in specificity and convenient to operate, and can detect vitamin B12-related substances in the multivitamin preparation quickly and efficiently, so that the quality of the multivitamin preparation is effectively controlled.

Description

technical field [0001] The invention relates to a method for detecting vitamin B in multivitamin preparations in the field of drug analysis 2 methods of matter. Background technique [0002] Vitamin B 12 (VitaminB 12 ), also known as cobalamin or cyanocobalamin, is a polycyclic compound containing 3-valent cobalt. Four reduced pyrrole rings are linked together to form a corrin macrocycle (similar to porphyrin), is vitamin B 12 The core of the molecule, the compounds containing this ring are called corrinoids, and they are the only vitamins containing metal elements. Vitamin B 12 It is a light red needle-like crystal, easily soluble in water and ethanol, most stable under weak acid conditions with a pH value of 4.5-5.0, decomposed in strong acids (pH<2) or alkaline solutions, and can be destroyed to a certain extent when heated, but short-term The loss of time for high temperature disinfection is small, and it is easily destroyed by strong light or ultraviolet rays. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 邵爱霞解洪福王晓伟
Owner 济南维瑞医药科技开发有限公司
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