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Detection method of daptomycin related substances

A technology for daptomycin and related substances, which is applied in the field of drug analysis and can solve the problems of poor reproducibility in separating the main peak and the adjacent peaks of the main peak, etc.

Inactive Publication Date: 2021-04-20
NANJING KING FRIEND BIOCHEM PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the relevant substance methods in the existing literature cannot effectively separate lactone hydrolyzate, anhydrodaptomycin, β-isomer, impurity 3 (RRT0.95), impurity 4 (RRT0.90), impurity 5 (RRT1 .07) and unknown impurities RRT0.82 and other impurities, and the used chromatographic column phenomenonex IB-SIL C8 (250mm×4.6mm×5μm) has poor reproducibility for separating the main peak and the adjacent peaks of the main peak, so it is urgent to develop a A detection method capable of effectively separating various impurities to accurately evaluate the quality of daptomycin products to ensure reliable quality and drug safety of the product

Method used

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  • Detection method of daptomycin related substances
  • Detection method of daptomycin related substances
  • Detection method of daptomycin related substances

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] 1. Chromatographic conditions

[0038] Instrument: high performance liquid chromatography;

[0039] Column: Waters Shield RP 18 250×4.6mm, 3.5μm;

[0040] Mobile phase: the volume ratio of mobile phase A (a mixed solution of anhydrous sodium sulfate and acetonitrile with a volume ratio of 74:26) and mobile phase B (a mixed solution of anhydrous sodium sulfate and acetonitrile with a volume ratio of 50:50) is 64:36 mixed solution;

[0041] Detection wavelength: 223nm;

[0042] Column temperature: 30°C;

[0043] Sample tray temperature: 4°C;

[0044] Flow rate: 0.5mL / min;

[0045] Injection volume: 10μL;

[0046] Running time: 75 minutes for the reference substance solution, 120 minutes for the test solution;

[0047] 2. Sample preparation

[0048] (1) Mobile phase preparation

[0049]Mobile phase A: the anhydrous sodium sulfate solution of 0.024mol / L (regulating pH with phosphoric acid is 3.5) and the volume ratio of acetonitrile is 74:26 mixed solution; Mobil...

Embodiment 2

[0060] 1. Chromatographic conditions

[0061] Instrument: high performance liquid chromatography;

[0062] Column: Waters Shield RP 18 250×4.6mm, 3.5μm;

[0063] Mobile phase: the volume ratio of mobile phase A (a mixed solution of anhydrous sodium sulfate and acetonitrile with a volume ratio of 74:26) and mobile phase B (a mixed solution of anhydrous sodium sulfate and acetonitrile with a volume ratio of 50:50) is 66:34 mixed solution;

[0064] Detection wavelength: 223nm;

[0065] Column temperature: 32°C;

[0066] Sample tray temperature: 4°C;

[0067] Flow rate: 0.5mL / min;

[0068] Injection volume: 10μL;

[0069] Running time: 120min for the test solution;

[0070] 2. Sample preparation

[0071] (1) Mobile phase preparation

[0072] Mobile phase A: the anhydrous sodium sulfate solution of 0.024mol / L (regulating pH with phosphoric acid is 3.5) and the volume ratio of acetonitrile is 74:26 mixed solution; Mobile phase B: the anhydrous sodium sulfate solution of 0...

Embodiment 3

[0078] 1. Chromatographic conditions

[0079] Instrument: high performance liquid chromatography;

[0080] Column: Waters Shield RP 18 250×4.6mm, 3.5μm;

[0081] Mobile phase: the volume ratio of mobile phase A (a mixed solution of anhydrous sodium sulfate and acetonitrile with a volume ratio of 74:26) and mobile phase B (a mixed solution of anhydrous sodium sulfate and acetonitrile with a volume ratio of 50:50) is 66:34 mixed solution;

[0082] Detection wavelength: 223nm;

[0083] Column temperature: 30°C;

[0084] Sample tray temperature: 4°C;

[0085] Flow rate: 0.4mL / min;

[0086] Injection volume: 10μL;

[0087] Running time: 120min for the test solution;

[0088] 2. Sample preparation

[0089] (1) Preparation of mobile phase: Carry out according to the method of "mobile phase" in Example 1.

[0090] (2) Preparation of the test solution: carry out according to the method of "preparation of the test solution" in Example 1.

[0091] 3. Experimental results

[...

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Abstract

The invention relates to a detection method of daptomycin related substances. The detection method adopts high performance liquid chromatography to qualitatively detect the daptomycin related substances, and the high performance liquid chromatography conditions are as follows: an embedded polar group C18 silica gel bonded phase is used as a chromatographic column; isocratic elution is carried out by adopting a mobile phase A and a mobile phase B in a volume ratio of (62-68): (38-32) as a mixed mobile phase; the mobile phase A is a mixed solution of an anhydrous sodium sulfate solution and acetonitrile in a volume ratio of (72-76): (28-24); and the mobile phase B is a mixed solution of an anhydrous sodium sulfate solution and acetonitrile in a volume ratio of (48-52): (52-48). The detection method disclosed by the invention can be used for detecting the generated impurities in the process of preparing the daptomycin or the daptomycin preparation, and is strong in specificity, good in reproducibility and accurate and reliable in result, so that the quality of the daptomycin or the daptomycin preparation product is accurately evaluated.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, in particular to a method for detecting daptomycin related substances. Background technique [0002] Daptomycin is an acidic ester peptide antibiotic produced by the fermentation of Streptomyces roseospora, molecular formula: C 72 h 101 N 17 o 26 , molecular weight: 1620.68, its structural formula is: [0003] [0004] Daptomycin is a new generation of cyclolipopeptide antibiotics marketed after vancomycin. It is used to treat complex skin infections, structural skin infections, heart infections and bacteremia caused by Gram-positive bacteria. It mainly changes the properties of the bacterial cell membrane by inhibiting the biosynthesis process of peptidoglymerase, the main component of the bacterial cell wall, so as to destroy the structure of the latter, making the bacterial cell membrane extremely fragile, and the cytoplasm and other important substances in the cell membrane leak ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
Inventor 唐咏群黄锡伟董海霞胡铮田欣欣
Owner NANJING KING FRIEND BIOCHEM PHARMA CO LTD