Supercharge Your Innovation With Domain-Expert AI Agents!

Detection method of linezolid product

A linezolid and detection method technology, applied in the field of detection of related substances in linezolid products, can solve the problems of unsatisfactory separation effect, failure to detect related substances, unsatisfactory separation degree, etc., to achieve good monitoring, Easy to prepare, good separation effect

Pending Publication Date: 2019-12-17
SICHUAN KELUN PHARMA RES INST CO LTD
View PDF7 Cites 3 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] However, compared with more than 20 kinds of related substances that may exist, the separation effect of these analytical methods (usually only a dozen kinds of impurities can be separated) is still not satisfactory, and they cannot detect all related substances
In addition, the degree of separation between the various substances is not ideal, and it is difficult to measure quantitatively accurately

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Detection method of linezolid product
  • Detection method of linezolid product
  • Detection method of linezolid product

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1 20

[0075] Example 1 Detection of twenty-two related substances

[0076] Solution preparation:

[0077] Diluent: methanol-water (10:90 by volume)

[0078] Impurity reference substance stock solution: Accurately weigh about 2.5 mg of the reference substances of the 22 substances listed in the above table 1, respectively, add an appropriate amount of methanol to a 25ml volumetric flask, dissolve it by ultrasonication, and dilute to volume with methanol, shake well, As impurity reference substance stock solution (100μg / ml).

[0079] System Suitability Solution 1: Take 20 mg of pure linezolid (Qionglai Branch of Sichuan Kelun Pharmaceutical Co., Ltd., purity: 99.96%), weigh it accurately, put it in a 100ml measuring bottle, and then pipette the above impurities separately for control 200 μl each of stock solution of each product, placed in the same 100ml volumetric bottle, added diluent to dissolve and dilute to the mark, shake well, filter, take the subsequent filtrate as system ...

Embodiment 2 20

[0090] Example 2 Detection of twenty-two related substances

[0091] Solution preparation:

[0092] Diluent: methanol-water (10:90 by volume)

[0093] Impurity reference substance stock solution: Accurately weigh about 2.5 mg of the reference substances of the 22 substances listed in the above table 1, respectively, add an appropriate amount of methanol to a 25ml volumetric flask, dissolve it by ultrasonication, and dilute to volume with methanol, shake well, As impurity reference substance stock solution (100μg / ml).

[0094] System Suitability Solution 2: Take 10 mg of pure linezolid (Qionglai Branch of Sichuan Kelun Pharmaceutical Co., Ltd., purity: 99.96%), accurately weigh it, put it in a 50ml measuring bottle, and then accurately pipette the above impurities for control Appropriate amount of product stock solution, put it in the same 50ml measuring bottle, add diluent to dissolve and dilute to the mark, shake well, filter, take the subsequent filtrate as system suitabil...

Embodiment 3 20

[0106] Example 3 Detection of twenty-two related substances

[0107] Prepare system suitability solution 2 according to the method of Example 2, and inject samples according to the chromatographic conditions of Example 2, and the elution procedure is as follows:

[0108] t(min) 0 20 50 55 56 65 A％ 92 72 20 20 92 92 B％ 8 28 80 80 8 8

[0109] Record the HPLC spectrum and count the experimental data. The experimental data and results are shown in Table 4, and the corresponding HPLC spectra are shown in image 3 , A total of 22 related substances were detected, 20 of which had a resolution of more than 1.5.

[0110] Table 4

[0111] Impurity name retention time (min) Separation Number of theoretical plates Z34 3.39 / 6089 Z20 4.79 8.26 12881 5-HMF 5.24 2.65 16257 Z31 5.79 2.84 10213 Z36 6.92 5.26 18798 Z30 8.08 5.57 22863 Z32 9.85 8.26 32778 Z39 10.72 3.99 38523 ...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

PropertyMeasurementUnit
volume ratioaaaaaaaaaa
volume ratioaaaaaaaaaa
separationaaaaaaaaaa
Login to View More

Abstract

The invention discloses a detection method of a linezolid product. According to the method, gradient elution is performed by adopting a mobile phase A and a mobile phase B for detection based on an HPLC. The mobile phase A is a solution formed by mixing a phosphoric acid aqueous solution with the volume concentration of 0.08 to 0.12% and methanol according to a volume ratio of (80-90) to (20-10) or a 0.2 to 1g / L ammonium dihydrogen phosphate aqueous solution; and the mobile phase B is methanol. The method is simple in mobile phase configuration and is capable of analyzing more than twenty related substances with high separation degree.

Description

technical field [0001] The application relates to a detection method for linezolid products, in particular to a method for detecting related substances in linezolid products by using HPLC to control its quality. Background technique [0002] Linezolid is a synthetic oxazolidinone antibiotic with the chemical name (S)-N[[3-[3-fluoro-4-(4-morpholinyl)phenyl]-2 -Oxo-5-oxazolidinyl]methyl]-acetamide, having the following chemical structure. [0003] [0004] In 2000, linezolid was approved by the US FDA for the treatment of infections caused by Gram-positive (G+) cocci, and was subsequently launched in countries and regions such as Australia, Canada, Britain, France, Korea, Hong Kong, Japan and China. Linezolid is a bacterial protein synthesis inhibitor that acts on the site on the 23S ribosomal RNA of the bacterial 50S subunit, thereby affecting the bacterial transcription process, that is, blocking bacterial protein synthesis, thereby exerting antibacterial effects. Due t...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88G01N30/02G01N30/36
CPCG01N30/02G01N30/36G01N30/88G01N2030/027G01N2030/8845
Inventor 许莉莉孙连福胡佰艳贺春荣郭瑾赵庆雅张丽沙王琳琳王利春王晶翼
Owner SICHUAN KELUN PHARMA RES INST CO LTD
Features
  • R&D
  • Intellectual Property
  • Life Sciences
  • Materials
  • Tech Scout
Why Patsnap Eureka
  • Unparalleled Data Quality
  • Higher Quality Content
  • 60% Fewer Hallucinations
Social media
Patsnap Eureka Blog
Learn More

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2025 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com