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Analytical detection method and application of polymyxin sulfate B

A polymyxin and detection method technology, applied in the field of polymyxin sulfate analysis and detection, can solve the problems of low sensitivity, low precision, long analysis time and the like, and achieve simple and rapid sensitivity, strong specificity and high sensitivity Effect

Active Publication Date: 2017-11-21
SPH NO 1 BIOCHEM & PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] The technical problem solved by the present invention is in order to overcome the poor specificity and low precision when adopting the antibiotic microbiological potency method to measure polymyxin B sulfate in the prior art, or adopting high performance liquid chromatography coupled with ultraviolet detector to detect polymyxin sulfate B When analyzing and detecting bacteriocin B, there are problems such as complex mobile phase preparation, low sensitivity, poor repeatability, long analysis time, etc., thereby providing an analysis and detection method of polymyxin B sulfate B and its application. The antibiotic microbiological potency method is specific and easy to operate, and can completely separate the four components without interference from other organic impurities. The effect is close to that of the HPLC method of EP 9.0 raw materials, with high sensitivity, simplicity and speed, and can be used more accurately. To determine the content of each component in polymyxin B sulfate preparation

Method used

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  • Analytical detection method and application of polymyxin sulfate B
  • Analytical detection method and application of polymyxin sulfate B
  • Analytical detection method and application of polymyxin sulfate B

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0073] Analytical method specificity and sensitivity

[0074] Experimental conditions:

[0075] Trifluoroacetic acid (HPLC grade, American Tiandi Co., Ltd.);

[0076] Acetonitrile (HPLC grade, Thermo Fisher Scientific Co., Ltd.);

[0077] Polymyxin B sulfate USP reference substance (batch number N1M425, containing B in every 100mg 1 69.7 mg, B 2 15.9 mg, B 3 3.2 mg, B 1 -I 6.1 mg);

[0078] High performance liquid chromatography: Alliance e2695 high performance liquid chromatography (Waters);

[0079] Evaporative light scattering detector: 2424 type evaporative light scattering detector (Waters);

[0080] Empower 3 high performance liquid chromatography data processing system;

[0081] Chromatographic column: Kromasil 100-5 C18 chromatographic column (5μm, 4.6×250mm);

[0082] Mobile phase A is 0.1% trifluoroacetic acid aqueous solution (pH value is 1.95), mobile phase B is acetonitrile, the gradient change of acetonitrile volume ratio is 0min to 5min, keeps at 24%;...

Embodiment 2

[0094] Linearity and Range of Analytical Methods

[0095] Experimental conditions

[0096] Experiments were carried out under similar experimental conditions as in Example 1. Polymyxin B sulfate USP reference substance (batch number N1M425, containing B in every 100mg 1 69.7 mg, B 2 15.9 mg, B 3 3.2 mg, B 1 -I 6.1 mg).

[0097] Experimental procedure

[0098] Accurately weigh 100mg of polymyxin B sulfate USP reference substance, place it in a 20mL volumetric flask, dissolve it in water-acetonitrile (80:20) and dilute to the mark, draw the mother solution 600μL, 800μL, 900μL, 1000μL, 1100μL , 1200μL, 1400μL, 2000μL and 3000μL were placed in 10mL volumetric flasks respectively, and diluted to volume as the control solution. Inject 20 μL of each of the above solutions and record the chromatograms. Taking the base 10 logarithm of the peak area of ​​each component as the abscissa, and taking the base 10 logarithm of the mass concentration of the corresponding component a...

Embodiment 3

[0102] Content detection of each component in polymyxin B sulfate raw material medicine

[0103] Experimental conditions

[0104] Experiments were carried out under similar experimental conditions as in Example 1. The only difference is: the gradient change of the volume ratio of acetonitrile is 0min to 5min, keeping at 24%; 5min to 8min, rising from 24% to 27%; 8min to 15min, rising from 27% to 30%; 15min to 20min, From 30% to 40%. The carrier gas pressure was 30 psi. The batch number of polymyxin B sulfate USP reference substance is N1M425, containing B in every 100mg 1 69.7 mg, B 2 15.9 mg, B 3 3.2 mg, B 1 -I 6.1 mg. The batch number of polymyxin B sulfate raw material drug is A1411105, purchased from Denmark Xellia Pharmaceutical Company.

[0105] Experimental procedure

[0106] Accurately weigh 50 mg of polymyxin B sulfate USP reference substance, place it in a 10 mL volumetric flask, dissolve it in water-acetonitrile (80:20) and dilute to the mark, draw the m...

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Abstract

The invention discloses an analytical detection method of polymyxin sulfate B, comprising the steps of analytically detecting polymyxin sulfate B via high-performance liquid chromatography in combination with an evaporative light scatterer. The method allows four components in polymyxin sulfate B to be fully separated, has high specificity, is simple to perform, is free of disturbance by other organic impurities, is approximately effective to HPLC (high-performance liquid chromatography) of EP 9.0 bulk pharmaceutical chemicals in terms of high sensitivity, good simplicity and high speed, and allows the contents of components in a polymyxin sulfate B preparation to be measured more accurately.

Description

technical field [0001] The invention relates to an analysis and detection method and application of polymyxin B sulfate. Background technique [0002] Polymyxin B (polymyxin B) is a basic polypeptide antibiotic composed of various amino acids and fatty acids produced by Bacillus polymyxa. The current production is mainly biosynthesized by microbial fermentation, and then extracted and refined. Its sulfate is clinically used, mainly as an anti-infection drug, to treat skin wounds, urinary system, eyes, ears, trachea and other infections caused by Gram-negative bacteria such as Pseudomonas aeruginosa, and can also be used for sepsis and peritonitis. Polymyxin B sulfate is a structurally similar multicomponent mixture, including polymyxin B 1 , B 2 , B 3 , B 1 -I. Among them, B 1 and B 2 is the active ingredient, B 3 and B 1 -I is the main impurity. The chemical structural formula is as follows: [0003] [0004] Specifically, polymyxin B 1 , B 2 , B 3 and B ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 贾存宇李晓倩陆倩黄臻辉
Owner SPH NO 1 BIOCHEM & PHARMA CO LTD
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