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Method for Impurity Analysis of Multivitamin Preparations

A technology for vitamin preparation and impurity analysis, applied in analytical materials, material separation, instruments, etc., can solve the problems of low ultraviolet absorbance of impurities, large differences in vitamin content, low ultraviolet absorbance, etc. The effect of enhanced absorption capacity and extended retention time

Active Publication Date: 2020-06-16
CHINESE MEDICINES GUANGZHOU
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Another prior art discloses the use of gas chromatography for detection, and the results show that the gasification temperature degrades dexpanthenol to generate pantothenic acid and 3-aminopropanol, which affects the accuracy of detection
3-Aminopropanol has strong polarity, almost no retention in reversed-phase chromatography, and low UV absorption
[0009] To sum up, the 13 kinds of vitamin preparations contain complex ingredients, and the content of each vitamin varies greatly. Among them, ingredients with large content and high polarity, such as vitamin C, niacinamide, dexpanthenol, vitamin B1, riboflavin sodium phosphate, etc. The detection of trace, highly polar and difficult-to-separate impurities (such as folic acid impurities) has a greater impact on the detection, and some impurities such as 3-aminopropanol have low UV absorption and low response values

Method used

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  • Method for Impurity Analysis of Multivitamin Preparations
  • Method for Impurity Analysis of Multivitamin Preparations
  • Method for Impurity Analysis of Multivitamin Preparations

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0079] Take the multivitamin preparation, dissolve it in water and dilute it to about 120 μg folic acid per 1 ml solution, as the test solution;

[0080] Take folic acid impurity A reference substance, folic acid impurity D reference substance, p-aminobenzoic acid reference substance and 3-aminopropanol reference substance, add 1ml 28mg / L sodium carbonate solution to dissolve, dilute with 10% methanol solution to every 1ml solution Containing 2.4 μg of folic acid impurity A, 2.4 μg of folic acid impurity D, 1.2 μg of p-aminobenzoic acid, and 3 μg of 3-aminopropanol, as the reference solution;

[0081] Take 25 mg of o-phthalaldehyde and 55 mg of 2-mercaptoethanol, add 0.5 ml of methanol to dissolve, and then add 5 ml of 0.4 mol / L boric acid buffer solution (adjust the pH value to 4.5 with phosphoric acid) to obtain a derivatization reagent;

[0082] Take 10 μL each of the above-mentioned test solution and reference solution, add 30 μL of derivatization reagents to carry out onl...

Embodiment 2

[0095] Take the multivitamin preparation, dissolve it in water and dilute it to about 120 μg folic acid per 1 ml solution, as the test solution;

[0096] Take folic acid impurity A reference substance, folic acid impurity D reference substance, p-aminobenzoic acid reference substance and 3-aminopropanol reference substance, add 1ml 28mg / L sodium carbonate solution to dissolve, dilute with 10% methanol solution to every 1ml solution Containing 2.4 μg of folic acid impurity A, 2.4 μg of folic acid impurity D, 1.2 μg of p-aminobenzoic acid, and 3 μg of 3-aminopropanol, as the reference solution;

[0097] Take 25 mg of o-phthalaldehyde and 55 mg of 2-mercaptoethanol, add 0.5 ml of methanol to dissolve, and then add 5 ml of 0.4 mol / L boric acid buffer solution (adjust the pH value to 4.5 with phosphoric acid) to obtain a derivatization reagent;

[0098] Take 10 μL each of the above-mentioned test solution and reference solution, respectively add 50 μL of derivatization reagent to c...

Embodiment 3

[0102] Take the multivitamin preparation, dissolve it in water and dilute it to about 120 μg folic acid per 1 ml solution, as the test solution;

[0103] Take folic acid impurity A reference substance, folic acid impurity D reference substance, p-aminobenzoic acid reference substance and 3-aminopropanol reference substance, add 1ml 28mg / L sodium carbonate solution to dissolve, dilute with 10% methanol solution to every 1ml solution Containing 2.4 μg of folic acid impurity A, 2.4 μg of folic acid impurity D, 1.2 μg of p-aminobenzoic acid, and 3 μg of 3-aminopropanol, as the reference solution;

[0104] Take 25 mg of o-phthalaldehyde and 55 mg of 2-mercaptoethanol, add 0.5 ml of methanol to dissolve, and then add 5 ml of 0.4 mol / L boric acid buffer solution (adjust the pH value to 4.5 with phosphoric acid) to obtain a derivatization reagent;

[0105] Take 10 μL each of the above-mentioned test solution and reference solution, add 30 μL of derivatization reagent for derivatizatio...

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Abstract

The invention relates to an impurity analysis method for multiple vitamin preparations. The method comprises the following steps of preparing a test solution of the vitamin preparations; dissolving o-phthalaldehyde and 2-mercaptoethanol based on a mass ratio of 1 to (2-5) in methanol, adding a boric acid buffer solution, and adjusting the pH value to 3-5 to obtain a derivatization reagent; and taking the test solution, adding the derivatization reagent to carry out online derivatization reaction, and injecting the derivatized test solution into a high performance liquid chromatograph, therebydetecting impurities in the test solution. According to the method, folic acid impurity A, folic acid impurity D, p-aminobenzoic acid and 3-aminopropanol in the vitamin preparations can be effectivelydetected; and the method is high in sensitivity and good in specificity.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to an impurity analysis method for multivitamin preparations. Background technique [0002] Vitamins are one of the essential nutrients for the human body, and can be divided into water-soluble vitamins and fat-soluble vitamins according to their solubility in aqueous solution. Water-soluble vitamins mainly include: thiamine (vitamin B1), riboflavin (vitamin B2), niacin (vitamin PP, niacin, niacinamide), pyridoxine (vitamin B6), cyanocobalamin (vitamin B12) , folic acid, pantothenic acid, biotin, ascorbic acid (vitamin C), etc., are easily soluble in water and can hardly be stored in the body. Fat-soluble vitamins mainly include vitamins A, D, E and K. As one of the essential nutrients for the human body, all vitamins are contained in a small amount in the body, but they play an important role in the metabolism, growth, and development of the body. The common characteristic...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 刘莉黄宏轩姚青
Owner CHINESE MEDICINES GUANGZHOU
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