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Method for determining components of freeze-dried powder injection containing multiple vitamins

A freeze-dried powder injection and component determination technology, applied in the field of analysis, can solve the problems of difficulty in analysis and detection, complex matrix, etc., and achieve the effect of reliable detection method, stable sample and improved accuracy

Pending Publication Date: 2020-08-07
费森尤斯卡比华瑞制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, products containing both water-soluble vitamins and fat-soluble vitamins are more difficult to analyze and detect due to their complex matrix
At the same time, vitamins are sensitive to external conditions such as light, heat, and oxygen, which is also a challenge for the reliability of the detection method.

Method used

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  • Method for determining components of freeze-dried powder injection containing multiple vitamins
  • Method for determining components of freeze-dried powder injection containing multiple vitamins
  • Method for determining components of freeze-dried powder injection containing multiple vitamins

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] A method for determining the components of a freeze-dried powder injection containing multiple vitamins, comprising the steps of:

[0043] 1) Preparation of reference substance solution: Accurately weigh 18 mg of vitamin B1 reference substance, 10 mg of vitamin B2 reference substance, 100 mg of vitamin B3 reference substance, 35 mg of vitamin B5 reference substance, 15 mg of vitamin B6 reference substance, 10 mg of vitamin B9 reference substance, and sodium vitamin C Reagent 40mg to 100mL volumetric flask, dissolved with mobile phase A and diluted to the mark to make a reference solution, injected into the liquid chromatograph.

[0044] 2) Preparation of the test solution: take a bottle of sample, add an appropriate amount of mobile phase A to dissolve, transfer to a 25mL volumetric flask, wash the sample bottle with mobile phase A several times, and transfer all the solution to a 25mL volumetric flask to Dilute mobile phase A to the mark, shake well, accurately measure...

Embodiment 2

[0068] A method for determining the components of a freeze-dried powder injection containing multiple vitamins, the determination of the standard recovery rate comprises the following steps:

[0069] 1) Preparation of standard addition solution: Accurately weigh 900 mg of vitamin B1 reference substance, 500 mg of vitamin B2 reference substance, 5000 mg of vitamin B3 reference substance, 1750 mg of vitamin B5 reference substance, 750 mg of vitamin B6 reference substance, 500 mg of vitamin B9 reference substance, and sodium vitamin C Reagent 40mg to 20mL volumetric flask, dissolved with mobile phase A and diluted to the mark to make reference standard addition solution;

[0070] 2) Preparation of the test solution: take a bottle of vitamin blank sample (does not contain vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B9), add an appropriate amount of mobile phase A to dissolve, transfer to a 25mL volumetric flask, Wash the sample bottle with mobile phase A se...

Embodiment 3

[0094] A method for determining the components of a freeze-dried powder injection containing multiple vitamins, the determination of the linear range comprises the following steps:

[0095] 1) Preparation of linear solution of reference substance: Precisely weigh 18 mg of vitamin B1 reference substance, 10 mg of vitamin B2 reference substance, 100 mg of vitamin B3 reference substance, 35 mg of vitamin B5 reference substance, 15 mg of vitamin B6 reference substance, 10 mg of vitamin B9 reference substance, and 10 mg of vitamin C Sodium reagent 40mg, into 25mL volumetric flask, dissolve with mobile phase A and dilute to the mark, from which respectively take 0mL, 2mL, 4mL, 5mL, 6mL, 8mL to 20mL volumetric flask, dilute with mobile phase A to the mark, make 6 Linear solutions of reference substances with different concentrations were injected into the liquid chromatograph.

[0096] 2) High-performance liquid chromatography detection: the sample to be tested is separated into the ...

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Abstract

The invention belongs to the technical field of analysis, and relates to a method for determining components of a freeze-dried powder injection containing multiple vitamins. According to the invention, the method comprises the steps: adopting the high performance liquid chromatography, wherein the chromatographic conditions are as follows: octadecylsilane chemically bonded silica is used as a chromatographic column filler; a potassium dihydrogen phosphate solution containing 0.05%-2% of triethylamine is used as a mobile phase A, methyl alcohol is used as a mobile phase B, and gradient elutionis conducted according to a certain procedure; the flow rate is 0.5 mL / min to 1.5 mL / min; the column temperature is 20-35 DEG C; the temperature of the sample injector is 2-25 DEG C; the sample size is 20 to 80mu L; and the detection wavelengths are 200 nm, 265 nm, 325 nm, 285 nm and 448 nm. According to the determination method disclosed by the invention, the antioxidant is added in a sample preparation process, so a sample is more stable; the method can improve the detection accuracy, and on the basis of actual product detection requirements, the method is suitable for products containing fat-soluble vitamins and water-soluble vitamins at the same time, and capable of detecting six vitamins at the same time, including vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6 and vitaminB9.

Description

technical field [0001] The invention belongs to the technical field of analysis, and relates to a method for determining components of a freeze-dried powder injection containing multiple vitamins. Background technique [0002] Vitamins are a type of trace organic substances that humans and animals must obtain from food in order to maintain normal physiological functions, and play an important role in the growth, metabolism, and development of the human body. This kind of substance is neither a raw material for body tissue nor a source of energy in the body, but a kind of regulating substance, which plays an important role in substance metabolism. Such substances cannot be synthesized or synthesized in insufficient amounts in the body, so although they are required in small quantities, they must be supplied by food frequently. [0003] In recent years, there have been more and more related vitamin products on the market, most of which are complex water-soluble vitamin produc...

Claims

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Application Information

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IPC IPC(8): G01N30/06G01N30/74
CPCG01N30/06G01N30/74
Inventor 孙惟沁陈晋苏邢珊珊何翠翠
Owner 费森尤斯卡比华瑞制药有限公司
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