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Method for detecting dalbavancin and impurities thereof

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: 2019-06-28
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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  • Method for detecting dalbavancin and impurities thereof
  • Method for detecting dalbavancin and impurities thereof
  • Method for detecting dalbavancin and impurities thereof

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Embodiment 1

[0053] 1) Preparation of standard reference substance solution: Accurately weigh dalbavancin standard substance, impurities A, B, and 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 substance and 0.25 mg each of impurities A, B, and C was dissolved as a standard reference substance;

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

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

Embodiment 2

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

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

[0063] Depend on image 3 Known: Dalbavansin B 0 The retention time of impurity A was 25.450min, the retention time of impurity A was 21.750min, the retention time of impurity B was 34.900min, and the retention time of impurity C was 30.467min. It achieves a good separation between impuritie...

Embodiment 3

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

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

[0068] Depend on Figure 5 Known: Dalbavansin B 0 The retention time of impurity A was 17.237min, the retention time of impurity A was 12.293min, the retention time of impurity B was 22.637min, and the retention time of impurity C was 20.210min. It achieves a good separation between impurit...

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Abstract

The invention discloses a method for detecting dalbavancin and impurities thereof. The method comprises the following steps: 1), preparing a standard reference solution for the dalbavancin and the impurities thereof; 2), preparing a test sample solution; 3), measuring a chromatogram of the dalbavancin and the impurities thereof in the standard solution by using a reversed-phase high performance liquid chromatograph, so that the resolution between any adjacent substances is higher than or equal to 1.5; 4), measuring a chromatogram of the test sample solution by using the reversed-phase high performance liquid chromatograph, and according to an area normalization method, determining the contents of the dalbavancin and each impurity thereof in the test sample solution. The invention providesthe conventional reversed-phase high performance liquid chromatography; by the method, the dalbavancin B0 and the impurities thereof as well as different impurities can be effectively separated, so that the content of the dalbavancin B0 can be accurately detected; in addition, the stability and the reliability are high; meanwhile, the method is relatively easy to operate 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 its impurities. Background technique [0002] Dalbavancin (Dalbavancin), also known as daugtomycin, is a new type of semi-synthetic glycopeptide antibiotic, a derivative of teicoplanin analogue A40926, discovered by Vicuron Pharmaceuticals in the United States, developed and entered clinical trials , 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 have shown 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 activ...

Claims

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Application Information

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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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