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Detection method of content of vitamin C in vinpocetine injection

A vinpocetine and detection method technology, applied in the field of analytical chemistry, can solve problems such as unstable properties of vitamin C, yellowing of solution color, and impact on product quality, and achieve simple and easy detection method, stable and durable standard addition recovery rate good sex effect

Inactive Publication Date: 2017-05-10
武汉华龙生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the nature of vitamin C is unstable, and it is easy to degrade under high temperature conditions. After the oxidation reaction, the color of the solution is easy to turn yellow, which affects the quality of the product. Therefore, the change of its content in Vinpocetine injection should also become the focus of attention
[0004] At present, the detection method of vitamin C content in vitamin C injection contained in the 2015 edition of the Pharmacopoeia of the People's Republic of China is a titration method. Vinpocetine injection contains the antioxidant sodium metabisulfite, which interferes with the detection results

Method used

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  • Detection method of content of vitamin C in vinpocetine injection
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  • Detection method of content of vitamin C in vinpocetine injection

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Embodiment 1

[0031] The specific steps of the present invention to determine the maximum absorption wavelength λmax of the vitamin C standard solution are as follows: take an appropriate amount of vitamin C, add mobile phase to dissolve and quantitatively dilute to a concentration of 10 μg / mL, and carry out in the range of 200 to 400 nm by a UV-visible spectrophotometer Spectrum scanning, the results are attached figure 1 As shown, vitamin C has a maximum absorption peak at a wavelength of 267nm.

Embodiment 2

[0033] The present invention draws the standard curve of vitamin C solution concentration and its corresponding chromatographic peak area A. The specific steps are as follows:

[0034] Precisely weigh vitamin C to prepare vitamin C solutions with concentrations of 2.5μg / ml, 12.5μg / ml, 25.0μg / ml, 37.5μg / ml, 50.0μg / ml, and 125.0μg / ml, and take each sample to be tested 10 μl of the solution was injected, and the chromatographic peak area of ​​each vitamin C solution was measured by high performance liquid chromatography at the maximum absorption wavelength λmax. The concentration (μg / ml) and peak area of ​​each concentration of vitamin C solution are shown in Table 1.

[0035] Chromatographic conditions of high-performance liquid chromatography: the chromatographic column is an InertSustain C18 column (4.6mm×250mm, 5μm), with octadecylsilane bonded silica gel as a filler; the maximum absorption wavelength λ max The column temperature is 30°C; the mobile phase is a mixture of ammo...

Embodiment 3

[0040] The present invention measures the specific steps of vitamin C content in Vinpocetine injection:

[0041] 1) Take an appropriate amount of samples 1 to 3 Vinpocetine injection preparations to be tested, and make a concentration of 25 μg / mL of the test solution;

[0042] 2) Accurately weigh an appropriate amount of pure vitamin C to make a reference substance solution with a concentration of 25 μg / mL;

[0043] 3) Take 15 μl of the test solution and the reference solution respectively and inject them into the high performance liquid chromatograph, at the maximum absorption wavelength λ max By measuring the chromatographic peak area of ​​need testing solution and reference substance solution;

[0044] 4) calculate the content of vitamin C in need testing solution according to following formula:

[0045]

[0046] In the formula, C is the content of vitamin C in the test solution, and the unit is μg / ml; A i For the peak area of ​​the test solution; A r Be the peak area ...

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Abstract

The invention discloses a detection method of the content of vitamin C in a vinpocetine injection. The detection method comprises the following steps: carrying out spectrum scanning through an ultraviolet-visible spectrophotometer to determine the maximum absorption wavelength lambdamax of a vitamin C standard solution; then preparing one group of vitamin C solutions with different concentrations and determining a chromatographic peak area of each vitamin C solution through a high performance liquid chromatograph under the maximum absorption wavelength lambdamax; drawing a standard curve of the vitamin C solutions and the corresponding chromatographic peak areas and solving a linear regression equation; meanwhile, determining a chromatographic peak area of a test sample solution through the high performance liquid chromatograph under the maximum absorption wavelength lambdamax; and finally, calculating the content of vitamin C in the test sample solution. According to the detection method disclosed by the invention, the content of vitamin C in the vinpocetine injection is detected by adopting an HPLC (High Performance Liquid Chromatography) method; and the detection method is simple, convenient and feasible, has high specificity and high accuracy and provides guarantees for safety, effectiveness and controllability of drugs.

Description

technical field [0001] The invention relates to the technical field of analytical chemistry, in particular to a method for detecting vitamin C content in vinpocetine injection. Background technique [0002] Vinpocetine is an alkaloid derivative extracted from the vinca vinca of Apocynaceae. Its active ingredient is apovincine ethyl ester. Vinpocetine was first developed by the Gedeon Richter pharmaceutical company in Hungary and was released in 1978. Since its launch in 2008, Vinpocetine Injection has been widely used in neurology, cardiovascular medicine, otology, ophthalmology, neurosurgery and other clinical departments due to its remarkable clinical effect and good safety and tolerance. Cerebrovascular routine medication. Vinpocetine has multiple effects and can improve brain metabolism, blood flow and hemorheological properties. [0003] Excipients in currently marketed Vinpocetine injections are generally vitamin C, sodium metabisulfite, L-tartaric acid, sorbitol, so...

Claims

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Application Information

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IPC IPC(8): G01N30/74G01N30/06G01N30/86
CPCG01N30/74G01N30/06G01N30/8634
Inventor 丛文娟丁冠军王世民黄楚华
Owner 武汉华龙生物制药有限公司
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