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A kind of detection method of cefotaxime sodium related substance

A technology of cefotaxime sodium and detection method, applied in the directions 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: 2022-05-20
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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  • A kind of detection method of cefotaxime sodium related substance
  • A kind of detection method of cefotaxime sodium related substance
  • A kind of detection method of cefotaxime sodium related substance

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] The present embodiment provides a method for the determination of related substances of cefotaxime sodium by high performance liquid chromatography, which is determined using the following conditions:

[0059] Chromatographic column: Octadecylsilane bonded silica gel is used as a filler, and a chromatographic column with a specification of CAPCELL PAK MGⅡC18 4.6×250mm and 5μm is selected;

[0060] Mobile phase A: phosphate buffer (weigh 7.1 g of anhydrous disodium hydrogen phosphate, add 1000 ml of water to dissolve, adjust the pH value 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°C;

[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] Gradient elution was used.

[0068] The gradient elution procedure is:

[0069] Table 3 Gradient el...

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 amount, add solvent respectively [in terms of volume ratio, mobile phase A: mobile phase B (90:10)] dissolve and dilute to make about impurity A, B, 10 μg each of C, D, E, and F, 2 μg each of impurity G, impurity H, and impurity I, and 1.5 μg each of impurities USP-A, USP-B, and USP-D, as the positioning solution for each impurity;

[0078] Preparation of the test solution: Get about 25 mg of cefotaxime sodium, accurately weighed, put in a 25 ml measuring bottle, add solvent [in volume ratio, mobile phase A: mobile phase B (90:10)] to dissolve and dilute to the scale, shake well, and you get it;

[0079] Preparation of referen...

experiment example 2

[0086] Experimental example 2 linearity and range test

[0087] Solvent: [by 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- Add appropriate amount of impurity D and cefotaxime sodium reference substance 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] Determination: Carry out according to the determination method condition of embodiment 1.

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

[0091] Table 5 Linearity and range test results

[0092]

[0093]

[0094] Table 6 Linearity an...

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Abstract

The invention relates to a method for detecting related substances of cefotaxime sodium, which uses high-performance liquid chromatography for detection, uses octadecylsilane bonded silica gel as the stationary phase, and uses a mixed solution of mobile phase A and mobile phase B as the mobile phase Phase, the mobile phase A is phosphate buffer, pH 6.0-7.0, the mobile phase B is methanol, pH 6.0-6.5, the chromatographic column is selected from the CAPCELL PAK MG series, and the tested Samples are tested. The method provided by the invention can separate cefotaxime sodium related substances (comprising cefotaxime sodium and 12 kinds of impurities) in high performance liquid chromatography; and through methodological verification, the sensitivity of each component detection is made and accuracy 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 was obtained by Roussel Uclaf, the predecessor of Sanofi-Aventis. Its German patent number DE2702501 (eidem); the US patent number of the same inventor is: US4152432; it was applied in 1977 and 1979 respectively, and it was listed in Germany in 1980. [0003] Cefotaxime is a third-generation cephalosporin with a broad antibacterial spectrum and strong activity against Gram-negative bacteria such as Escherichia coli, Proteus mirabilis, Klebsiella, and Salmonella. 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 Pseudomonas aeruginosa and Alcaligenes. Cefotaxim...

Claims

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Application Information

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Patent Type & Authority Patents(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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