Method for detecting content of daptomycin

A daptomycin and detection method technology, applied in the field of organic matter analysis, can solve the problems of high instrument price and maintenance cost, relatively high professional quality requirements for operators, and unpopular application, and achieve short inspection cycle, good linear relationship, The effect of low detection cost

Pending Publication Date: 2022-03-25
LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0027] The liquid chromatography-mass spectrometer used in this method is a high-end instrument in the organic matter analysis market. The instrument price and subsequent maintenance costs are expensive, and the professional quality requirements for operators are relatively high. LC / MS is still in development in pharmaceutical companies. stage, the application is not yet popular

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  • Method for detecting content of daptomycin
  • Method for detecting content of daptomycin
  • Method for detecting content of daptomycin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0073] A method for detecting daptomycin content, comprising the steps of:

[0074] S1, the step of obtaining daptomycin sample chromatographic peak area according to the following chromatographic conditions:

[0075] Detection instrument: Agilent 1260InfinityⅡ liquid chromatograph;

[0076]Chromatographic column: C18 column (BDS Hypersil C18, 4.6×250mm, 5μm);

[0077] Mobile phase A: potassium dihydrogen phosphate-acetonitrile solution (take potassium dihydrogen phosphate 3.2-3.6g, add water 1000mL to dissolve, adjust the Ph value to 3.0 with phosphoric acid, filter and add 300mL acetonitrile, ultrasonic degassing);

[0078] Mobile phase B: acetonitrile;

[0079] The opening ratio of mobile phase A to mobile phase B is = 65:35;

[0080] Flow rate: 1.0mL / min;

[0081] Running time: 10min;

[0082] Elution mode: isocratic;

[0083] Detection wavelength: 223nm;

[0084] Column temperature: 25°C;

[0085] Autosampler temperature: 5°C;

[0086] Injection volume: 5 μL;

...

Embodiment 2

[0091] A method for detecting daptomycin content, comprising the steps of:

[0092] S1, the step of obtaining daptomycin sample chromatographic peak area according to the following chromatographic conditions:

[0093] Detection instrument: Agilent 1260InfinityⅡ liquid chromatograph;

[0094] Chromatographic column: C18 column (BDS Hypersil C18, 4.6×250mm, 5μm);

[0095] Mobile phase A: potassium dihydrogen phosphate-acetonitrile solution (take potassium dihydrogen phosphate 3.2-3.6g, add water 1000mL to dissolve, adjust the Ph value to 3.0 with phosphoric acid, filter and add 300mL acetonitrile, ultrasonic degassing);

[0096] Mobile phase B: acetonitrile;

[0097] The opening ratio of mobile phase A to mobile phase B is = 65:35;

[0098] Flow rate: 1.0mL / min;

[0099] Running time: 10min;

[0100] Elution mode: isocratic;

[0101] Detection wavelength: 223nm;

[0102] Column temperature: 30°C;

[0103] Autosampler temperature: 5°C;

[0104] Injection volume: 50μL;

...

Embodiment 3

[0109] A method for detecting daptomycin content, comprising the steps of:

[0110] S1, the step of obtaining daptomycin sample chromatographic peak area according to the following chromatographic conditions:

[0111] Detection instrument: Agilent 1260InfinityⅡ liquid chromatograph;

[0112] Chromatographic column: C18 column (BDS Hypersil C18, 4.6×250mm, 5μm);

[0113] Mobile phase A: potassium dihydrogen phosphate-acetonitrile solution (take potassium dihydrogen phosphate 3.2-3.6g, add water 1000mL to dissolve, adjust the Ph value to 3.0 with phosphoric acid, filter and add 300mL acetonitrile, ultrasonic degassing);

[0114] Mobile phase B: acetonitrile;

[0115] The opening ratio of mobile phase A to mobile phase B is = 65:35;

[0116] Flow rate: 1.0mL / min;

[0117] Running time: 10min;

[0118] Elution mode: isocratic;

[0119] Detection wavelength: 223nm;

[0120] Column temperature: 23°C;

[0121] Autosampler temperature: 5°C;

[0122] Injection volume: 5 μL;

...

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Abstract

The invention belongs to the technical field of organic matter analysis, and particularly relates to a daptomycin content detection method which comprises the following steps: S1, obtaining the peak area of a daptomycin sample chromatographic peak according to the following chromatographic conditions: a stationary phase is a C18 chromatographic column; a mobile phase A is a monopotassium phosphate-acetonitrile solution; a mobile phase B is acetonitrile; the opening ratio of the mobile phase A to the mobile phase B is 65: 35; the retention time is 6.0 + / -0.5 min; the sample size is 5-50 [mu] L; s2, substituting the obtained peak area of the chromatographic peak of the daptomycin sample into a formula y = 9.0319 x + 88.334, so as to obtain the concentration of the daptomycin in the daptomycin sample, in the formula, x refers to the peak area of the chromatographic peak of the daptomycin sample; and y refers to the concentration of the daptomycin. The daptomycin content detection method provided by the invention is high in detection precision and low in detection difficulty.

Description

technical field [0001] The invention belongs to the technical field of organic matter analysis, in particular to a method for detecting the content of daptomycin. Background technique [0002] Daptomycin is an N-decanoyl derivative of the lipopeptide compound A21978C, a fermentation product of Streptomyces roseospora. It contains 13 amino acids, of which 10 amino acids form a ring deca lipopeptide, and the other 3 amino acids are connected with decanoyl to form a side chain , is the second generation of glycopeptide antibiotics after vancomycin. The existing standard detection method for the content of daptomycin is the UPLC-MS / MS method for the determination of daptomycin plasma concentration jointly issued by the Medical Department of Zhongda Hospital Affiliated to Southeast University and the Medical Department of China Pharmaceutical University. The detection conditions are as follows: [0003] Detection instrument: Nexera X2 liquid chromatograph-API140000 mass spectrom...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 黎靖李帅徐文灿黄新华王为民
Owner LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO LTD
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