Method for detecting isomer in briviact injection by using high performance liquid chromatography

A high-performance liquid chromatography, briracetam technology, applied in the field of drug quality determination, can solve the problems of small differences in structure and polarity, difficult separation, etc., and achieve the effects of good control and accurate detection.

Pending Publication Date: 2022-02-22
YANGTZE RIVER PHARM GRP SICHUAN HAIRONG PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the structural and polar differences between several stereoisomers are small and difficult to separate
As a result, there is currently no effective method for the detection of isomers in Brivaracetam injection

Method used

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  • Method for detecting isomer in briviact injection by using high performance liquid chromatography
  • Method for detecting isomer in briviact injection by using high performance liquid chromatography
  • Method for detecting isomer in briviact injection by using high performance liquid chromatography

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Experimental program
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Effect test

Embodiment 1

[0045] Embodiment 1: The method for detecting the isomer in Briracetam injection by high performance liquid chromatography

[0046] The instrument used in this embodiment is an Agilent 1260 liquid chromatograph.

[0047] The chromatographic conditions adopted in this embodiment are as follows:

[0048] Chromatographic column: LUX i-Amylose-3 (4.6mm×250mm, 5μm);

[0049] Mobile phase: 20mM potassium dihydrogen phosphate aqueous solution-acetonitrile (8:2), adjust the pH value to 7.5;

[0050] Flow rate: 1.0ml / min, wavelength: 205nm, column temperature: 30°C, injection volume: 20μl.

[0051] The concrete steps of this embodiment are as follows:

[0052] (1) System suitability experiment

[0053] Take an appropriate amount of Brivaracetam reference substance and isomer impurity reference substance, dilute according to the concentration shown in Table 1 to prepare a mixed solution, and this mixed solution is used as a system suitability solution.

[0054] Table 1 Concentratio...

Embodiment 2

[0064] Embodiment 2: The influence of mobile phase flow rate on Briracetam and isomer separation degree

[0065] The chromatographic conditions used in this example are basically the same as those in Example 1, the only difference being that the flow rate of the mobile phase has been changed. In this embodiment, the conditions of mobile phase flow rates of 0.8ml / min, 1.0ml / min and 1.2ml / min were investigated respectively. The system suitability solution used in this example is the same as that in Example 1. Under the conditions of three mobile phase flow rates, the HPLC chromatograms of the system suitability solution are as follows: Figure 2-4 As shown, the test results are shown in Table 3.

[0066] Table 3 The effect of mobile phase flow rate on Brivaracetam and the separation of isomers

[0067]

[0068] It can be seen from the test results of this embodiment that slightly changing the flow rate of the mobile phase has little effect on the retention time and resolut...

Embodiment 3

[0069] Example 3: The influence of chromatographic column temperature on Briracetam and adjacent peak resolution

[0070] The chromatographic conditions adopted in this embodiment are basically the same as those in Example 1, the only difference being that the column temperature of the chromatographic column is changed. In this embodiment, the conditions under which the column temperature of the chromatographic column is 25° C., 30° C. and 35° C. are investigated respectively. The system suitability solution used in this example is the same as that in Example 1. Under the conditions of three mobile phase flow rates, the HPLC chromatograms of the system suitability solution are as follows: Figure 5-7 As shown, the test results are shown in Table 4.

[0071] Table 4 Effect of column temperature on the separation of Brivaracetam and its isomers

[0072]

[0073] It can be seen from the test results of this embodiment that slightly changing the column temperature of the chr...

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Abstract

The invention belongs to the technical field of medicine quality determination, and particularly relates to a method for detecting an isomer in a briviact injection by using high performance liquid chromatography. In order to solve the problem that the method for accurately detecting the isomer in the briviact injection is lacked in the prior art, the technical scheme of the invention is as follows: (1) taking the briviact injection, and diluting the briviact injection to serve as a test solution; (2) detecting the test solution by adopting a high performance liquid chromatography, and judging whether isomer impurities exist or not according to impurity peaks in a map; the chromatographic conditions of the high performance liquid chromatography are as follows: a mobile phase adopts phosphate buffer solution-acetonitrile, and a chromatographic column adopts amylose-tri (3-chloro-5-methyl phenyl carbamate) bonded silica gel as a filling agent. By adopting the chromatographic conditions, the accurate detection of the isomer in the briviact injection can be realized.

Description

technical field [0001] The invention belongs to the technical field of drug quality measurement, and in particular relates to a method for detecting isomers in briracetam injection by using high performance liquid chromatography. Background technique [0002] Brivaracetam, a 2-pyrrolidone derivative, has a highly selective affinity for the brain-specific binding site synaptophysin 2A (SV2A), which may be the main target of its pharmacological activity. The pharmacology of Brivaracetam is similar to that of the antiepileptic drug Levetiracetam, but it has higher selectivity and affinity for SV2A, and its mode of action does not involve high voltage activation of calcium channel currents and inhibition of AMPA gating currents. Nonclinical (rat) data indicate that brivaracetam penetrates the brain more rapidly than levetiracetam. [0003] Brivaracetam was developed by UCB Pharma SA, and was approved for marketing in EMA and the United States on January 14, 2016 and February 18...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 阎雨石宇华肖雷刘齐忠樊丽
Owner YANGTZE RIVER PHARM GRP SICHUAN HAIRONG PHARM CO LTD
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