Method for detecting content of A40926 and related substances

A mobile phase and gradient technology, applied in the field of analysis, can solve the problems of poor data detection reproducibility, damaged chromatographic column, low resolution, etc., and achieve the effect of good reproducibility, strong practicability and strong specificity

Pending Publication Date: 2019-11-05
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0021] This method is for B 0 In the early stage, many impurity peaks with similar properties could not be separated, and the resolution of various components was low, and due to the low elution strength of the method, some 0 Small related substances cannot be eluted, so the B 0 Purity and related substances are tested
If it is used for a long time, it will easily cause damage to the chromatographic column, and the accuracy and sensitivity of data analysis will be affected during continuous sample injection.
This method has a large gradient change, and there is no equilibration time before the elution of the main components and related substances, resulting in poor reproducibility of data detection, and it is impossible to locate completely according to the retention time

Method used

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  • Method for detecting content of A40926 and related substances
  • Method for detecting content of A40926 and related substances
  • Method for detecting content of A40926 and related substances

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] Chromatographic conditions

[0059] Chromatographic column: C 8 , the column specification is 4.6mm×250mm, 5μm;

[0060] Detection wavelength: 280nm;

[0061] Column temperature: 45°C;

[0062] Flow rate: 1.0mL / min;

[0063] mobile phase:

[0064] Mobile phase A: The volume ratio of 0.024mol / L ammonium dihydrogen phosphate solution to acetonitrile is 95:5, pH=5.5~6.0;

[0065] Mobile phase B: The volume ratio of 0.024mol / L ammonium dihydrogen phosphate solution to acetonitrile is 45:55, pH=5.5~6.0;

[0066] The elution gradient is as follows:

[0067]

[0068] Solution preparation:

[0069] Accurately measure blank solution, test solution, A40926-B 0 Each 20 μL of the control solution was injected into the high-performance liquid chromatograph, and the chromatogram was recorded, and the retention time, peak height, theoretical plate number and resolution were calculated. The test results are shown in Table 1.

[0070] Table 1

[0071]

[0072] As can be ...

Embodiment 2

[0074] Chromatographic conditions

[0075] Chromatographic column: C 8 , the column specification is 4.6mm×250mm, 5μm;

[0076] Detection wavelength: 280nm;

[0077] Column temperature: 40°C;

[0078] Flow rate: 1.0mL / min;

[0079] mobile phase:

[0080] Mobile phase A: The volume ratio of 0.02mol / L ammonium dihydrogen phosphate solution to acetonitrile is 95:5, pH=5.5~6.0;

[0081] Mobile phase B: The volume ratio of 0.02mol / L ammonium dihydrogen phosphate solution to acetonitrile is 45:55, pH=5.5~6.0;

[0082] The elution gradient is as follows:

[0083]

[0084]

[0085] Solution preparation is as described in embodiment 1;

[0086] Accurately measure blank solution, test solution, A40926-B 0 Each 20 μL of the control solution was injected into the high-performance liquid chromatograph, and the chromatogram was recorded, and the retention time, peak height, main peak area, theoretical plate number and resolution were calculated. The test results are shown in T...

Embodiment 3

[0091] Chromatographic conditions

[0092] Chromatographic column: C 8 , the column specification is 4.6mm×250mm, 5μm;

[0093] Detection wavelength: 280nm;

[0094] Column temperature: 55°C;

[0095] Flow rate: 1.0mL / min;

[0096] mobile phase:

[0097] Mobile phase A: The volume ratio of 0.03mol / L ammonium dihydrogen phosphate solution to acetonitrile is 95:5, pH=5.5~6.0;

[0098] Mobile phase B: 0.03mol / L ammonium dihydrogen phosphate solution and acetonitrile volume ratio is 45:55, pH=5.5~6.0;

[0099] The elution gradient is as follows:

[0100]

[0101]

[0102] Solution preparation is as described in embodiment 1;

[0103] Accurately measure blank solution, test solution, A40926-B 0 Each 20 μL of the control solution was injected into the high-performance liquid chromatograph, and the chromatogram was recorded, and the retention time, peak height, main peak area, theoretical plate number and resolution were calculated. The test results are shown in Table 3...

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Abstract

The invention belongs to the technical field of analysis, and particularly provides a method for detecting the content of A40926 and related substances, adopting a chromatographic column using octyl or octadecyl silane bonded silica gel as a filler, and ammonium dihydrogen phosphate-acetonitrile solution as a mobile phase. By using the method, the content of main component B0 in the A40926 can beaccurately detected, and related substances in the A40926 can be accurately separately detected. The simple, convenient and efficient detection method is provided for quality control in the A40926 production process. The high-performance liquid chromatography has the advantages of good sensitivity, high accuracy, strong data reproducibility and good durability.

Description

technical field [0001] The invention belongs to the technical field of analysis, and in particular relates to a method for detecting the content of A40926 and related substances. Background technique [0002] Dalbavancin is a new semi-synthetic glycopeptide antibiotic with the precursor of A40926. Dalbavancin has good antibacterial activity against Gram-positive bacteria, and its mechanism of action is the same as that of vancomycin and teicoplanin. It is mainly used for the treatment of complicated skin and soft tissue infections caused by Gram-positive bacteria. Due to its stronger antibacterial activity in vivo and longer half-life, dalbavancin is currently the most ideal second-generation glycopeptide antibiotic. On May 23, 2014, the US Food and Drug Administration (FDA) approved dalbavancin for marketing. [0003] At present, A40926, the precursor of dalbavancin, is mainly produced through microbial fermentation. The A40926 obtained from the fermentation broth throug...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 张贵民刘志钰李旭娇
Owner LUNAN PHARMA GROUP CORPORATION
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