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Determination method of related substance of cefodizime sodium for injection

A technology for cefodizime sodium and related substances, applied in the field of medicine and biology, can solve problems such as hidden safety hazards, allergic reactions, and reduced drug efficacy, and achieve the effects of reducing the interference of baseline noise, simple operation, and improving accuracy

Inactive Publication Date: 2014-12-17
SICHUAN PHARMA
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  • Summary
  • Abstract
  • Description
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AI Technical Summary

Problems solved by technology

[0004] The impurities in the medicine will affect the purity of the product, and the excessive amount of impurities will easily cause the allergic reaction of the medicine, cause the safety hazard of the medicine, affect the stability of the medicine, and reduce the curative effect of the medicine, especially cefodizime sodium in the production and During storage, related substances of cefodizime sodium and polymers of cefodizime sodium are likely to be produced, affecting the stability of the product

Method used

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Embodiment 1

[0020] The method for determination of related substances of cefodizime sodium for injection adopts isocratic elution high performance liquid chromatography, and selects 220nm as the detection wavelength, in which 0.1mol / L phosphate buffer with pH 7.0 is used as mobile phase A, Using deionized water as mobile phase B, inject the two mobile phases A and B into the chromatograph, and then inject the 0.1 mg / ml blue dextran 2000 solution into the chromatograph to obtain the A and B mobile phase blue dextran 2000 The peak retention time ratio is between 0.95-1.05.

[0021] The method for determination of related substances of cefodizime sodium for injection includes the following steps:

[0022] (1) Test applicability: Inject the mobile phase B into the chromatograph for 5 consecutive injections;

[0023] (2) Establish a linear equation to establish a good injection volume range for the cefodizime reference substance;

[0024] (3) Establish a reproducibility experiment: Inject mobile phas...

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Abstract

The invention discloses a determination method of related substances of cefodizime sodium for injection. With an isocratic elution method and 220nm detection length, the end adsorption of cefodizime sodium for injection is reduced, the interference of base line noise can be reduced, the accuracy and the flexibility of detection are improved, the operation is simple and the method has practical value.

Description

[0001] Technical field [0002] The invention involves the field of pharmaceutical biology and specifically, involving the measurement method of cephalosporin sodium sodium sodium. Background technique [0003] Cefidine sodium is the third -generation broad -spectrum semi -syndromes developed by Hoest Company and Rusell.Cefidine sodium has a broad -spectrum antibacterial activity and long -term effect, and there are other third -generation semi -semi -synthesis of immune regulatory activity.This is mainly because the sodium sodium of cephalospalin contains a unique replacement base of 2-cymbal-4-methyl-5-chimodolid acid.Clinically, it is mainly used for upper and lower urinary tract infections caused by staphylococcus, rinmococcus, and most of Gram -negative bacteria, lower respiratory tract infections, gonorrhea, etc. [0004] The impurities in the drug will affect the purity of the product, and too much miscellaneous quality can easily cause the allergic reactions of the drug t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 王强张静文刘萍
Owner SICHUAN PHARMA
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