Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

Method for simultaneously detecting multiple residual solvents in ceftriaxone sodium

A residual solvent and detection head technology is applied in the field of simultaneous detection of various residual solvents in ceftriaxone sodium, which can solve the problem that the detection method cannot meet the requirements, and achieve the effects of high accuracy, simple operation and good repeatability

Active Publication Date: 2014-01-01
SHANGHAI NEW ASIA PHARMA
View PDF6 Cites 27 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The object of the present invention is to: provide a kind of method that detects multiple residual solvents in ceftriaxone sodium simultaneously, to overcome the defective that existing organic solvent detection method can't meet demand

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 simultaneously detecting multiple residual solvents in ceftriaxone sodium
  • Method for simultaneously detecting multiple residual solvents in ceftriaxone sodium
  • Method for simultaneously detecting multiple residual solvents in ceftriaxone sodium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment Construction

[0056] 1 Instruments and reagents

[0057] Agilent6890N gas chromatograph; Agilent7694E headspace sampler; ceftriaxone sodium (batch number: TQ0043); DMSO is HPLC grade, and other reagents are of analytical grade.

[0058] 2 Chromatographic conditions

[0059] Chromatographic column: capillary column with 100% polydimethylsiloxane as stationary liquid (HP-1 60m×530μm×5.00μm);

[0060] Carrier gas: N 2 ;

[0061] Ascending heating: keep at 40°C for 4 minutes, then start at 20°C˙min -1 The temperature is raised to 150°C at a rate of 6 minutes;

[0062] The inlet temperature is 200°C (split ratio: 1:1, column head pressure 7.70psi);

[0063] Detector: hydrogen flame ionization detector (FID);

[0064] Detector temperature: 250°C;

[0065] Headspace equilibrium temperature: 60°C;

[0066] Headspace equilibration time: 30min;

[0067] With DMSO as solvent.

[0068] 3 Preparation of solution

[0069] 3.1 Preparation of reference substance stock solution

[0070] Ac...

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 relates to a method for simultaneously detecting multiple residual solvents in ceftriaxone sodium, which adopts a gas chromatographic analysis process to simultaneously detect six organic solvents in medicines, including methanol, ethanol, acetonitrile, acetone, ethyl acetate and triethylamine. The gas chromatographic process is adopted to simultaneously detect the contents of the six organic solvents, and has the advantages of high sensitivity, favorable repetitiveness and high precision; by using a standard addition process, the method does not need any additional standard substance as an internal standard, only needs a pure substance for predicting components, can counteract the matrix effect, and is simple to operate; by using a headspace sampling process, the method prevents the direct solution sample from interfering with detection and from polluting the chromatographic column; and a programmed heating process is adopted to effectively separate low-boiling-point organic solvents from high-boiling-point organic solvents.

Description

technical field [0001] The invention relates to a gas chromatography detection method, in particular to a method for simultaneously detecting multiple residual solvents in ceftriaxone sodium. Background technique [0002] Drug residual solvents refer to volatile organic chemical substances used or generated during the production process of raw materials, excipients or preparations. These solvents that are not completely removed during the production process not only reduce the stability of the drug and affect the quality, but also increase the toxicity and carcinogenicity of the patient after taking it. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) classified 69 organic solvents commonly used in drug production and purification processes according to their degree of harm to the human body and the environment. into 4 categories. For the first, second and third types of solvents, the residual a...

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
IPC IPC(8): G01N30/88G01N30/06
Inventor 郑玉林沈宏一姜文婷管海英
Owner SHANGHAI NEW ASIA PHARMA
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products