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Method for detecting cefotaxime sodium related substances

A technology of cefotaxime sodium and detection method, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problem of inability to separate and detect 12 known impurities in cefotaxime sodium, poor antibacterial activity of Staphylococcus aureus, inability to Quality and other issues, to achieve the effect of convenient quality inspection and monitoring, good specificity and high reproducibility

Active Publication Date: 2020-02-21
BEIJING YUEKANGKECHUANG PHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This product has poor antibacterial activity against Staphylococcus aureus, strong activity against Gram-positive cocci such as hemolytic streptococcus and Streptococcus pneumoniae, and enterococci are resistant to this product
[0004] At present, the existing cefotaxime sodium impurity detection method cannot effectively separate and detect 12 known impurities in cefotaxime sodium, and cannot carry out strict quality control. Applicable detection methods for 12 impurities

Method used

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  • Method for detecting cefotaxime sodium related substances
  • Method for detecting cefotaxime sodium related substances
  • Method for detecting cefotaxime sodium related substances

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] This embodiment provides a method for the determination of related substances of cefotaxime sodium by high performance liquid chromatography, and the determination is performed under the following conditions:

[0059] Chromatographic column: use octadecyl silane bonded silica gel as a filler, and select a chromatographic column with specifications of CAPCELL PAK MGⅡC18 4.6×250mm, 5μm;

[0060] Mobile phase A: Phosphate buffer (weigh 7.1g of anhydrous disodium hydrogen phosphate, add 1000ml of water to dissolve, adjust the pH to 6.25 with phosphoric acid);

[0061] Mobile phase B: methanol; adjust the pH to 6.0-6.5 with phosphoric acid;

[0062] Column temperature: 25℃;

[0063] Detection wavelength 1: 235nm;

[0064] Flow rate: 1.0mL / min;

[0065] Solvent: by volume ratio, mobile phase A: mobile phase B (90:10);

[0066] Injection volume: 10μL

[0067] Use gradient elution.

[0068] The gradient elution procedure is:

[0069] Table 3 Gradient elution program

[0070]

[0071]

[0072] T...

experiment example 1

[0076] Experimental example 1 System suitability test

[0077] Preparation of each impurity positioning solution: accurately weigh cefotaxime sodium impurity A, impurity B, impurity C, impurity D, impurity E, impurity F, impurity G, impurity H, impurity I, USP-impurity A, USP-impurity B , USP-impurity D and cefotaxime reference substance in appropriate amounts, respectively, add a solvent [in volume ratio, mobile phase A: mobile phase B (90:10)] to dissolve and dilute to make each 1mL containing impurities A, B, C, D, E, F each 10μg, impurity G, impurity H, impurity I 2μg, impurity USP-A, USP-B, USP-D concentration of each 1.5μg solution, as each impurity positioning solution;

[0078] Preparation of test solution: Take about 25mg of cefotaxime sodium, accurately weigh it, place it in a 25ml measuring flask, add solvent [in volume ratio, mobile phase A: mobile phase B (90:10)] to dissolve and dilute To the mark, shake well and get;

[0079] Preparation of reference solution: accura...

experiment example 2

[0086] Experimental example 2 Linearity and range test

[0087] Solvent: [in terms of volume ratio, mobile phase A: mobile phase B (90:10)]

[0088] Linear sample solution: accurately weigh cefotaxime sodium impurity A, impurity B, impurity C, impurity D, impurity E, impurity F, impurity G, impurity H, impurity I, USP-impurity A, USP-impurity B, USP- Impurity D and cefotaxime sodium reference substance are each appropriate amount, respectively add solvent [in terms of volume ratio, mobile phase A: mobile phase B (90:10)] to dissolve and dilute into a series of linear sample solutions, shake well, and get ready.

[0089] Measurement: According to the conditions of the measurement method in Example 1.

[0090] Precisely measure 10 μL of each of the above solutions, inject it into the liquid chromatograph, and record the chromatogram. The results are shown in Tables 5-6.

[0091] Table 5 Linearity and range test results

[0092]

[0093]

[0094] Table 6 Linearity and range test results

...

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Abstract

The invention relates to a method for detecting cefotaxime sodium related substances. The detection method uses a high performance liquid chromatography for detection; Octadecyl silane bonded silica is used as a stationary phase; a mixed solution of a mobile phase A and a mobile phase B is adopted as a mobile phase, wherein the mobile phase A is a phosphate buffer solution, and the pH value is 6.0-7.0; the mobile phase B is methanol, and the pH value is 6.0-6.5; a chromatographic column is selected from CAPCELL PAK MG series, and a sample to-be detected is detected in a gradient elution manner. According to the method provided by the invention, cefotaxime sodium related substances (including cefotaxime sodium and 12 impurities) can be separated in a high performance liquid chromatogram; through methodology verification, the sensitivity and the accuracy of detection of each component are further improved.

Description

Technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a method for detecting related substances of cefotaxime sodium. Background technique [0002] The invention patent of Cefotaxime (Cefotaxime) was obtained by the French company Roussel Uclaf, the predecessor of Sanofi-Aventis. Its German patent number DE2702501 (eidem); the same inventor's US patent number: US4152432; applied for in 1977 and 1979, respectively, and went on the market in Germany in 1980. [0003] Cefotaxime is a third-generation cephalosporin with a broad antibacterial spectrum. It has strong activity against Gram-negative bacteria such as Escherichia coli, Proteus mirabilis, Klebsiella, Salmonella and other Enterobacteriaceae. Cefotaxime sodium for injection also has a good effect on Proteus vulgaris and Citrobacter. Enterobacter cloacae and Enterobacter aerogenes are relatively resistant to this product. This product has no antibacterial activity against P...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/74
CPCG01N30/02G01N30/06G01N30/34G01N30/74
Inventor 宋更申李中伟高金双李同进张婷婷
Owner BEIJING YUEKANGKECHUANG PHARM TECH CO LTD
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