Method for determining content of cisatracurium besilate for injection by using high performance liquid chromatograph

A technology of cisatracurium besylate and high performance liquid chromatography, applied in the field of medicine, can solve the problems of difficult analysis, mismatch between inspection time and production time, and many impurities, so as to reduce environmental pollution and shorten content determination time. , the effect of reducing the discharge volume

Pending Publication Date: 2020-12-18
SHANGHAI PHARMA DONGYING JIANGSU PHARMA CO LTD
View PDF5 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For a two-day production batch, the overall inspection time is too long, and the inspection time does not match the production time
It should also be explained here that this variety has many impurities (13 known impurities or other unknown impurities), which is difficult to analyze. If other high-performance liquid chromatography methods with a shorter time are selected, it may cause the impurities to be separated from the main components. Do not open, the content is falsely high, and there is a certain risk to the safety of human medicine

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
  • Method for determining content of cisatracurium besilate for injection by using high performance liquid chromatograph
  • Method for determining content of cisatracurium besilate for injection by using high performance liquid chromatograph
  • Method for determining content of cisatracurium besilate for injection by using high performance liquid chromatograph

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0025] The chromatographic conditions of the present invention are as follows: adopt ultra-high performance liquid chromatography (UPLC), use octadecyl bonded silica gel as a filler; -Acetonitrile (75:5:20) as mobile phase A, with 1.02% potassium dihydrogen phosphate buffer solution (adjust the pH value to 3.1 with phosphoric acid)-methanol-acetonitrile (50:30:20) as mobile phase B, press Table 2 carries out gradient elution; the detection wavelength is 280nm; the flow rate is 1.0ml / min.

[0026] Table 2 Gradient elution table of mobile phase A and mobile phase B

[0027]

[0028] Operation steps of the present invention are as follows:

[0029] 1. Preparation of the test solution: Take 10 bottles of this product, place each in a 25ml measuring bottle, dissolve it with mobile phase A and adjust the volume to the mark, shake well, and make a solution containing about 0.2mg of cisatracurium per 1ml , as the test solution, a total of 10 samples were prepared;

[0030] 2. Pr...

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

No PUM Login to view more

Abstract

The invention discloses a method for determining the content of cisatracurium besilate for injection by using a high performance liquid chromatograph. The method comprises the following steps: (1) preparing a test solution; (2) preparing a reference substance solution; (3) carrying out determination. According to the method disclosed by the invention, the content determination time of the varietyis greatly shortened, and when the method is used in stability and other researches, the cost can be reduced, the efficiency can be increased, the emission volume of hazardous wastes can be greatly reduced, and the emission of 2L of waste liquid every 24 hours is reduced to 0.16 L of waste liquid every 24 hours from the original emission volume of 2L of waste liquid every 24 hours, so that the environmental pollution is reduced.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a method for determining the content of cisatracurium besylate for injection by a high-performance liquid chromatography, which is used for the content determination of cisatracurium besylate for injection. Background technique [0002] In the current industry, the method for determining the content of cisatracurium besylate for injection is high performance liquid chromatography. (See the 2020 edition of "Chinese Pharmacopoeia" P761 to P763) [0003] Original chromatographic conditions: adopt high performance liquid chromatography (HPLC), use octadecyl bonded silica gel as a filler; use 1.02% potassium dihydrogen phosphate buffer solution (adjust the pH value to 3.1 with phosphoric acid)-methanol-acetonitrile (75 : 5:20) as mobile phase A, with 1.02% potassium dihydrogen phosphate buffer solution (adjust the pH value to 3.1 with phosphoric acid)-methanol-acetonitrile (50:30:...

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): G01N30/88
CPCG01N30/88G01N2030/8809
Inventor 姜丽华张志新
Owner SHANGHAI PHARMA DONGYING JIANGSU PHARMA CO LTD
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Try Eureka
PatSnap group products

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

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap