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Method for separating and measuring related impurities in acrivastine and preparation thereof

A technology of impurities and preparations, applied in the field of analytical chemistry, to achieve high sensitivity, excellent separation performance and durability, and short separation time

Active Publication Date: 2018-03-23
CHONGQING HUAPONT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] There is no published method to report the method for separation and determination of Avastin and its impurities

Method used

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  • Method for separating and measuring related impurities in acrivastine and preparation thereof
  • Method for separating and measuring related impurities in acrivastine and preparation thereof
  • Method for separating and measuring related impurities in acrivastine and preparation thereof

Examples

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Effect test

Embodiment 1

[0045] Example 1 Method for Separating and Determining Avastatin and Its Related Impurities

[0046] 1) Protect from light, take an appropriate amount of Avastin, add mobile phase to dissolve and dilute to make a solution containing about 200 μg of Avastin per 1ml, as the test sample solution; accurately measure 1ml, put it in a 100ml measuring bottle , dilute to the mark with mobile phase, shake well, and use it as a control solution.

[0047] 2) Take an appropriate amount of Avastin reference substance, put it in a quartz volumetric flask, add mobile phase to ultrasonically dissolve and quantitatively dilute to make a solution containing about 200 μg of Avastin per 1 ml, and light it in a 5000 lx light box for 48 hours as a system adaptability Solution, take 20 μl into the liquid chromatograph, record the chromatogram, the order of peaks is impurity Ⅰ, impurity Ⅱ, impurity Ⅲ, impurity Ⅳ, impurity Ⅴ and Avastin peak, the number of theoretical plates is calculated according to...

Embodiment 2

[0050] Embodiment 2 Separation and determination of Avastin capsules and the method for its related impurities

[0051] 1) Protect from light, take an appropriate amount of the content of Avastin capsules (approximately equivalent to 20mg of Avastin), put it in a 100ml brown measuring bottle, add mobile phase ultrasound and shake for 10 minutes from time to time to make Avastin Tin dissolved, and diluted to the mark with the mobile phase, shaken, filtered, and the filtrate was used as the test sample solution; 1ml was accurately measured, put in a 100ml measuring bottle, diluted to the mark with the mobile phase, shaken up, as a contrast solution.

[0052] 2) Take an appropriate amount of Avastin reference substance, put it in a quartz volumetric flask, add mobile phase to ultrasonically dissolve and quantitatively dilute to make a solution containing about 200 μg of Avastin per 1 ml, and light it in a 5000 lx light box for 48 hours as a system adaptability Solution, take 20 μl ...

Embodiment 3

[0055] Example 3 Method for Separating and Determining Avastin Capsules and Related Impurities

[0056] Except that the mobile phase proportioning that adopts is different, all the other conditions are identical with embodiment 2.

[0057] The volume ratio of acetonitrile, tetrahydrofuran and 0.5% triethylamine aqueous solution in the mobile phase is 15:5:80.

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Abstract

The invention belongs to the field of analytical chemistry, and specifically relates to a method for separating and measuring related impurities in acrivastine and a preparation thereof. According tothe method, octadecyl silane bonded silica gel is adopted as a solid phase, and a mobile phase consisting of aqueous solutions of acetonitrile, tetrahydrofuran and triethylamine is adopted for elutionfor solid-liquid separation; the related impurities include one or more of a double oxidation impurity I, a single oxidation impurity II, Z-type III, E-type IV and E-isomer V. According to the methodprovided by the invention, the related impurities in the acrivastine and the preparation thereof are separated and detected by high performance liquid chromatography, and can be totally separated anddetected within 18 minutes; the method has the advantages of high separation degree, strong specificity, high sensitivity, easiness in operation, simpleness and quickness, so as to guarantee that thequality of the acrivastine and the preparation thereof is controllable, and finally determines the safety and effectiveness of a product, and is of great significance to quality control on the acrivastine.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, and in particular relates to a method for separating and measuring related impurities in avastatin and its preparations. Background technique [0002] Avastatin is a moderately potent competitive histamine H1 receptor antagonist, belonging to the phenazine class of antihistamines. The structural formula of Avastin is as shown in formula I, is the antiallergic drug released by Glaxo Wellcome Company in the late 1980s, is a derivative of Triprolidine, and its molecular formula is C 22 h 24 N 2 o 3 , the molecular weight is 348.444, the chemical name is (E,E)-3-[6-[1-(4-methylphenyl)-3-(1-pyrrolidinyl)-1-propenyl]-2-pyridine Base]-2-acrylic acid is a second-generation antihistamine drug with a pyrrolamine structure, and it is a highly competitive histamine H 1 Receptor antagonist has no obvious anticholinergic effect, has low penetration ability to the central nervous system, and has good cu...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/74
CPCG01N30/02G01N30/74
Inventor 赵静刘阔薛倩
Owner CHONGQING HUAPONT PHARMA
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