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Method for detecting cefixime polymer impurities

A technology of cefixime dimer and cefixime, which is applied in the directions of measuring devices, instruments, scientific instruments, etc., can solve the problems of poor peak shape of cefixime polymers, and achieves wide application range and good detection effect. Effect

Active Publication Date: 2020-08-18
GUANGZHOU BAIYUNSHAN PHARMA HLDG CO LTD BAIYUNSHAN PHARMA GENERAL FACTORY
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AI Technical Summary

Benefits of technology

This patented technology allows us to accurately identify any harmful substances found on drugs like ceftriptimes without having them mixed up with other chemicals already made from this drug. It also helps monitor if there're no residual compounds left behind during production.

Problems solved by technology

This patented technical problem addressed in this patents relates to improving the accuracy and precision of detecting polymorphisms within certain types of carbapenems called Ceftodecavir®(CEP) due to their unique properties. Specifically, these polymers may cause issues like contaminants affecting biological activity and causing unwanted effects when administered through routes other than those mentioned above. To solve this issue, methods were proposed including separation techniques based upon differences between solubility constants associated with each type of compound.

Method used

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  • Method for detecting cefixime polymer impurities
  • Method for detecting cefixime polymer impurities
  • Method for detecting cefixime polymer impurities

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] The preparation of embodiment 1 stock solution

[0064] Preparation of diluent solution: 0.075 mol / L anhydrous disodium hydrogen phosphate: 0.075 mol / L anhydrous sodium dihydrogen phosphate=61:39.

[0065] Sensitivity solution preparation: Accurately measure an appropriate amount of the control solution, dilute it with a diluent to make a solution containing about 0.5 mg of cefixime per 1 ml, and use it as a sensitivity solution.

[0066] Preparation of test solution: get cefixime granules (G1802001 batch), add appropriate amount of diluent, dissolve by ultrasonic, dilute with diluent to make a solution containing cefixime 1mg per 1ml, filter, discard 2.0ml First filtrate, get the continued filtrate as need testing solution;

[0067] Preparation of control solution: Accurately measure an appropriate amount of the test solution, and dilute it with a diluent to prepare a solution containing about 1 μg of cefixime per 1 ml, as a control solution.

[0068] Preparation of ...

Embodiment 2

[0069] Embodiment 2 system suitability test

[0070] Take an appropriate amount of cefixime polymer system suitability reference substance, add phosphate buffer (0.075mol / L anhydrous disodium hydrogen phosphate: 0.075mol / L anhydrous sodium dihydrogen phosphate=61:39) to dissolve and dilute to prepare Each 1ml contains about 1mg of cefixime, 2mg of polymer impurity B and 2mg of dimer D, take 20ml and inject it into the liquid chromatograph, record the chromatogram, the separation degree of polymer impurity B and dimer D should meet Require.

Embodiment 3

[0071] The detection of polymer impurity in the cefixime granule of embodiment 3

[0072] Chromatographic column: Hypersil Gold C18, 4.6mm×250mm, 3μm;

[0073] Mobile phase: mobile phase A is 0.1% formic acid solution, and mobile phase B is acetonitrile.

[0074] Flow rate: 1.0ml / min;

[0075] Detection wavelength: 254nm;

[0076] Column temperature: 35°C;

[0077] Injection volume: 20 μL.

[0078] Gradient elution program: as shown in Table 3.

[0079] Table 3 Gradient elution program

[0080]

[0081]

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Abstract

The invention relates to the technical field of medicine quality detection, in particular to a method for detecting cefixime polymer impurities. According to the method, high performance liquid chromatography is used for detection, and the detection conditions of the high performance liquid chromatography comprise that a mobile phase is composed of a mobile phase A and a mobile phase B, the mobilephase A is a formic acid solution, and the mobile phase B is acetonitrile, methanol or acetonitrile-methanol; and the volume ratio of the mobile phase A to the mobile phase B is (20-95): (80-5). According to the method for detecting the cefixime polymer impurities, the cefixime polymer impurities can be effectively detected, and the problems that an original detection method is poor in specificity, and most of the detected impurities are not polymer impurities are solved.

Description

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Claims

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Application Information

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Owner GUANGZHOU BAIYUNSHAN PHARMA HLDG CO LTD BAIYUNSHAN PHARMA GENERAL FACTORY
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