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A method for simultaneously detecting multiple residual solvents in ceftriaxone sodium

A technology of residual solvent and detection head, which is applied in the field of simultaneous detection of multiple residual solvents in ceftriaxone sodium, can solve the problems that the detection method cannot meet the demand, and achieve high accuracy, offset matrix effect, and good repeatability

Active Publication Date: 2016-04-20
SHANGHAI NEW ASIA PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

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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

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  • A method for simultaneously detecting multiple residual solvents in ceftriaxone sodium
  • A method for simultaneously detecting multiple residual solvents in ceftriaxone sodium
  • A method for simultaneously detecting multiple residual solvents in ceftriaxone sodium

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Embodiment Construction

[0056] 1 Instruments and reagents

[0057] Agilent6890N gas chromatograph; Agilent7694E headspace sampler; ceftriaxone sodium (batch number: TQ0043); DMSO was HPLC grade, and the rest of the reagents were of analytical grade.

[0058] 2 Chromatographic conditions

[0059] Chromatographic column: capillary column with 100% polydimethylsiloxane as stationary liquid (HP-160m×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

[007...

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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) has classified 69 organic solvents commonly used in drug production and purification into 4 categories according to their degree of harm to the human body and the environment. For the first, second and third types of solvents, the residual amount in...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/88G01N30/06
Inventor 郑玉林沈宏一姜文婷管海英
Owner SHANGHAI NEW ASIA PHARMA
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