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Method for measuring vincamine related substances through high performance liquid chromatography (HPLC)

A related substance, vincamine technology, applied in the field of drug analysis

Inactive Publication Date: 2014-06-18
ZHANG JIA GANG VINSCE BIO PHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] There is a great demand for vincamine in the international market, and it can be semi-synthesized at present. There are many synthetic routes. There are almost no domestic reports on the control of its raw materials and intermediates. The Chinese Pharmacopoeia has no quality control standards related to it. An efficient, fast, accurate and specific HPLC method is of great significance for the detection and control of its related substances

Method used

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  • Method for measuring vincamine related substances through high performance liquid chromatography (HPLC)
  • Method for measuring vincamine related substances through high performance liquid chromatography (HPLC)
  • Method for measuring vincamine related substances through high performance liquid chromatography (HPLC)

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Pure vincamine was purchased from European sigma company with a purity of 99.83%. The high-performance liquid chromatograph uses the American Agilent1260 model instrument, the detector is a DAD detector, the chromatographic column is thermo C18, 4.6 × 250mm, 5μm, the detection wavelength is 260nm, the injection volume: 5μl (G1315D automatic sampler), the flow rate 1ml / min, column temperature: 35°C, mobile phase: acetonitrile-0.1M ammonium carbonate solution (7:3) isocratic elution.

[0023] Experimental steps:

[0024] Get vincamine pure product 25mg, mobile phase ultrasonic dissolving, be mixed with the need testing solution that vincamine concentration is 1mg / ml.

[0025] Get vincamine standard substance 25mg, mobile phase ultrasonic dissolving, be mixed with the standard substance solution that vincamine concentration is 1mg / ml, get above-mentioned standard substance solution appropriate amount, mobile phase dilution 500 times, be mixed with the concentration that ...

Embodiment 2

[0034] Experiments were carried out using similar equipment and operating steps as in Example 1, and the intermediates in the synthesis of vincamine in our company were measured and quality controlled.

[0035] The high-performance liquid chromatograph uses the American Agilent1260 model instrument, the detector is a VWD detector, the chromatographic column is thermo C18, 4.6×150mm, 5μm, the detection wavelength is 260nm, the injection volume: 5μl (G1315D automatic sampler), the flow rate is 1ml / min, column temperature: 35°C, mobile phase: acetonitrile-0.1M ammonium carbonate solution (7:3) isocratic elution.

[0036] Experimental steps:

[0037] Take 0.1ml of the final reaction solution of intermediate Ⅰ for the synthesis of vincamine and the final reaction solution of intermediate Ⅱ for the synthesis of vincamine, respectively, and dilute the mobile phase to 10ml as the qualitative control solution of vincamine-related substances. In addition, get 25 mg of vincamine finish...

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Abstract

The invention relates to a method for measuring vincamine related substances through high performance liquid chromatography (HPLC). The method is characterized in that an octadecyl bonded silica chromatographic column is selected, an acetonitrile-0.1M ammonium carbonate solution (7:3) serves as a mobile phase for performing isocratic elution, a detector is an ultraviolet detector, and the detection wavelength is 260nm. The method has the characteristics of high separation degree, simplicity, rapidness, high specificity, high sensitivity and the like and can be used for detection and quality control of possibly generated related substances comprising intermediates, byproducts and other organic impurities in the vincamine preparation process.

Description

technical field [0001] The invention relates to a method for measuring vincamine-related substances by using an HPLC method, in particular to a method for determining intermediates in the process of synthesizing vincamine, and belongs to the field of drug analysis. Background technique [0002] Vincamine is an alkaloid isolated from the oleander plants Vinca major, V. minor, V. erecta, and V. dilormis. Vincamine is a cerebral vasodilator, which can maintain or restore the physiological expansion of cerebral blood vessels, increase the normal cerebral blood flow in the ischemic area, improve the utilization rate of blood oxygen in the brain, and improve the metabolism of hypoxic brain tissue. [0003] There is a great demand for vincamine in the international market. It can be semi-synthesized at present. There are many synthetic routes. There are almost no domestic reports on the control of its raw materials and intermediates. The Chinese Pharmacopoeia has no quality control...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 彭学东张梅赵金召祁亚楠
Owner ZHANG JIA GANG VINSCE BIO PHARM
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