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A method for detecting dalbavancin and its impurities

A technology of impurity and solution, applied in the field of detection of dalbavancin and its impurities, to achieve the effects of easy implementation, accurate detection and simple operation

Active Publication Date: 2022-05-24
LIVZON NEW NORTH RIVER PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

CN107121505A, document "B in A40926 mixture 0 "Separation and Purification of Components" respectively reported the detection methods for dalbavancin impurity 3-dimethylaminopropylamine and its finished product, but there was no research report on the content of dalbavancin and the separation of related impurities produced during the synthesis process

Method used

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  • A method for detecting dalbavancin and its impurities
  • A method for detecting dalbavancin and its impurities
  • A method for detecting dalbavancin and its impurities

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Embodiment 1

[0053] 1) Preparation of standard reference solution: Accurately weigh dalbavancin standard product, impurities A, B, C, add a mixed solution of acetonitrile and water (volume ratio 3:7, hereinafter referred to as acetonitrile aqueous solution) to dissolve, and prepare each mL of a solution containing 1 mg of dalbavancin standard and 0.25 mg of impurities A, B, and C each, as a standard reference substance to dissolve;

[0054]2) Preparation of test sample solution: accurately weigh 20 mg of dalbavancin test product in a 20mL volumetric flask, add acetonitrile aqueous solution to dissolve and dilute to the scale line, as test sample solution;

[0055] 3) Determination by high performance liquid chromatography: The chromatographic test conditions are as follows: chromatographic column: Purospher RP-18, 4.6 mm×250 mm, 5 μm; mobile phase: acetonitrile: NaH 2 PO 4 ·2H 2 O(0.06mol / L, pH=6.0)=30:70(v / v), carry out isocratic elution, elution time 60min; flow rate: 1.0mL / min; column...

Embodiment 2

[0061] The detection method of embodiment 2 is consistent with embodiment 1, and difference lies in the chromatographic condition of step 3):

[0062] 3) Determination by high performance liquid chromatography: The chromatographic test conditions are as follows: chromatographic column: Purospher RP-18, 4.6 mm×250 mm, 5 μm; mobile phase: acetonitrile: NaH 2 PO 4 (0.06mol / L, pH=6.0)=28:72 (v / v), carry out isocratic elution, elution time 60min; flow rate: 1.0mL / min; column temperature: 40℃; UV detector detection wavelength: 208nm; injection volume: 20μL, see the chromatogram of the standard reference solution image 3 , see the chromatogram of the test sample solution Figure 4 :

[0063] Depend on image 3 Known: Dabawan Star B 0 The retention time is 25.450min, impurity A retention time is 21.750min, impurity B retention time is 34.900min, impurity C retention time is 30.467min, the separation degree between any adjacent peaks is greater than 2.0, which indicates that dalb...

Embodiment 3

[0066] The detection method of embodiment 3 is consistent with embodiment 1, and difference lies in the chromatographic condition of step 3):

[0067] 3) Determination by high performance liquid chromatography: The chromatographic test conditions are as follows: chromatographic column: Purospher RP-18, 4.6 mm×250 mm, 5 μm; mobile phase: acetonitrile: NaH 2 PO 4 (0.06mol / L, pH=6.0)=30:70 (v / v), carry out isocratic elution, elution time 60min; flow rate: 1.1mL / min; column temperature: 40℃; UV detector detection wavelength: 208nm; injection volume: 20μL, see the chromatogram of the standard reference solution Figure 5 , see the chromatogram of the test sample solution Image 6 :

[0068] Depend on Figure 5 Known: Dabawan Star B 0 The retention time is 17.237min, impurity A retention time is 12.293min, impurity B retention time is 22.637min, impurity C retention time is 20.210min, the separation degree between any adjacent peaks is greater than 2.0, which indicates that dal...

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Abstract

The invention discloses a method for detecting dalbavancin and its impurities. The method comprises the steps of: 1) preparing a standard reference substance solution of dalbavancin and its impurities; 2) preparing a test sample solution; 3) using a reversed-phase high-performance liquid chromatograph to measure dalbavancin in the standard solution chromatogram of its impurities, so that the separation between any adjacent substances ≥ 1.5; 4) use reversed-phase high-performance liquid chromatography to measure the chromatogram of the test sample solution, and determine the concentration of the test sample solution according to the area normalization method. The content of dalbavancin and its impurities. The invention provides conventional reversed-phase high-performance liquid chromatography, which can make Bavancin B 0 Effective separation between impurities and impurities and impurities, so that dalbavancin B can be accurately detected 0 content, and high stability and reliability, while the operation is relatively simple and easy to implement.

Description

technical field [0001] The invention relates to the field of drug analysis, in particular to a method for detecting dalbavancin and impurities thereof. Background technique [0002] Dalbavancin, also known as daucomycin, is a new semi-synthetic glycopeptide antibiotic, a derivative of teicoplanin analog A40926, discovered, developed and entered into clinical trials by Vicuron Pharmaceuticals, USA , later acquired by Pfizer. [0003] The mechanism of action of dalbavancin is the same as that of vancomycin and teicoplanin. It inhibits the biosynthesis of the cell wall of G+ bacteria and is widely used as a drug for the treatment of skin and soft tissue infections. In vivo and in vitro tests show that dalbavancin has antibacterial properties against G+ bacteria including methicillin-resistant Staphylococcus aureus (MRSA), methicillin-sensitive Staphylococcus aureus (MSSA), coagulase-negative staphylococcus (CoNS), and streptococcus. active. It is active against G+-resistant ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
Inventor 陈月嫦谢伟健冯绮晴姜桥卢增杰
Owner LIVZON NEW NORTH RIVER PHARMA
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