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Acetic acid atosiban, and method for detecting content of preparation of acetic acid atosiban and relevant substances

A technology of atosiban acetate and related substances is applied in the field of content determination of atosiban acetate and preparations thereof and related substance determination, can solve problems such as difficult separation completely, and achieves strong specificity, strong operability, Accurate and sensitive effects

Active Publication Date: 2010-04-21
HAINAN ZHONGHE PHARM CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The detection method of related substance and content of atosiban acetate and atosiban acetate injection has not been reported yet, and the difficulty of its determination method is that missing (incomplete) peptide, fragmentation peptide, de- Amide polypeptides, diastereoisomeric polypeptides and oligomers and other process impurities, after purification by chromatography, the impurities that cannot be removed are similar to the chromatographic behavior of the main drug, and it is not easy to completely separate them

Method used

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  • Acetic acid atosiban, and method for detecting content of preparation of acetic acid atosiban and relevant substances
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  • Acetic acid atosiban, and method for detecting content of preparation of acetic acid atosiban and relevant substances

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Embodiment 1

[0035] Determination method of atosiban acetate

[0036] Experimental equipment and chromatographic conditions:

[0037] Waters 515-717-2996 high-performance liquid chromatograph, Agilent C18 chromatographic column (5 μ m, 150 × 4.6mm), with the phosphate buffer solution of 0.05mol / L (take potassium dihydrogen phosphate 6.8g, add water 1000ml, adjust with phosphoric acid pH value to 2.0 ~ 3.0, then add 120μl triethylamine, to get) as mobile phase A, acetonitrile as mobile phase B, carry out gradient elution, detection wavelength is 205 ~ 225nm; flow rate is 0.8 ~ 1.2ml / min; The sample volume is 5-200 μl. .

[0038] Reagent:

[0039] Acetonitrile (HPLC grade) was from American Tiandi Company, and ultrapure water was made by Millipore ultrapure water machine.

[0040] Choice of Chromatographic Conditions

[0041] 1.1 mobile phase

[0042] We have compared 0.1% trifluoroacetic acid (TFA): acetonitrile (ACN) and 0.05mol / L phosphate buffer saline (PBS): ACN by experiment, wit...

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Abstract

The invention relates to an acetic acid atosiban, and a method for detecting content of preparation of acetic acid atosiban and relevant substances. The detection method is an efficient liquid-phase chromatography method, which comprises the following chromatography conditions that a chromatographic column takes octadecylsilane chemically bonded silica (C18) as filling agent; 0.05mol / L phosphate buffer solution is taken as mobile phase A and acetonitrile as mobile phase B to carry out gradient elution; a detection wavelength ranges from 205 to 225nm; the flow speed ranges between 0.8 and 1.2ml / min and the concentration of a prepared sample ensures that each milliliter of the sample contains 0.1 to 15mg of polypeptide; and the sample size is controlled between 5 and 200mu l. The efficient liquid-phase chromatography method can accurately detect a sample and the content of impurities of the sample at the same time and realizes complete sample separation during analysis and ideal reproducibility of analysis result, thereby providing a simple and reliable method for quality control and analysis during production process.

Description

Technical field: [0001] The invention relates to a method for detecting active polypeptide raw materials and preparations, in particular to a method for determining the content of atosiban acetate and its preparations and related substances. Background technique: [0002] Atosiban (atosiban), its chemical name is: 1-(3-mercaptopropanol acid)-2-(O-ethyl-D-tyrosine)-4-L-threonine-8-L - Ornithine - Oxytocin. [0003] Its structural formula is: [0004] [0005] Atosiban is an oxytocin analog, a synthetic cyclic polypeptide, and a competitive antagonist of oxytocin on receptors in the uterus, decidua, and fetal membrane. Its acetate is used clinically to treat premature labor . Atosiban Acetate Injection (AtosibanAcetate Injection) was developed by Ferring AB and was first launched in Austria on March 23, 2000. The trade name is: [0006] The detection method of related substance and content of atosiban acetate and atosiban acetate injection has not been reported yet, a...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 崔学云周宗贞杨平马中刚王文付建兴
Owner HAINAN ZHONGHE PHARM CO LTD
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