Method for simultaneously measuring content of main components and main impurities in cefotaxime sodium tazobactam sodium for injection

A technology of cefotaxime sodium and tazobactam sodium is applied in the field of drug analysis to achieve the effects of high accuracy, strong pertinence and good stability

Inactive Publication Date: 2018-11-13
JIANGSU LINGBAO PHARMA
View PDF2 Cites 5 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Through literature search, it is found that there is no literature report capable of simultaneously determining the content of main components and main impurities in cefotaxime sodium and tazobactam sodium for injection

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Method for simultaneously measuring content of main components and main impurities in cefotaxime sodium tazobactam sodium for injection
  • Method for simultaneously measuring content of main components and main impurities in cefotaxime sodium tazobactam sodium for injection
  • Method for simultaneously measuring content of main components and main impurities in cefotaxime sodium tazobactam sodium for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Embodiment one: determination of assay method.

[0047] 1. Determination of chromatographic conditions:

[0048] Use the following chromatographic conditions to screen for the best detection method:

[0049] Chromatographic conditions (1):

[0050] Refer to the chromatographic condition test under the related substances of cefotaxime sodium in the 7th edition of the European Pharmacopoeia, wherein:

[0051] Chromatographic column: Waters XBridge Shield C18 (5μm, 250mm×4.6mm) chromatographic column;

[0052] Mobile phase: mixed phosphate buffer (take 3.5g potassium dihydrogen phosphate and 11.6g disodium hydrogen phosphate, add 1000mL water to dissolve, adjust the pH value to 7.0 with phosphoric acid)-methanol (100:18v / v);

[0053] Elution method: isocratic elution;

[0054] Mobile phase flow rate: 1.0mL / min;

[0055] Injection volume: 10μL;

[0056] Detection wavelength: 235nm.

[0057] Solution preparation (1):

[0058] Weigh about 10 mg of cefotaxime reference...

Embodiment 2

[0139] Embodiment 2: methodological validation of the assay method.

[0140] 1. Validation of impurity analysis method:

[0141] The establishment process of the assay method is described in Example 1, and the following experiments in this example are used to illustrate the advantages of the assay method.

[0142] ●Exclusiveness:

[0143] (1) Acid damage:

[0144] Sample acid destruction solution: Weigh about 50 mg of cefotaxime sodium and tazobactam sodium for injection (batch number: 20110102), accurately weigh it, place it in a 50 mL volumetric flask, add 1 mL of hydrochloric acid solution (0.1 mol / L), and store at room temperature Stand for 30 minutes, add an equal amount of sodium hydroxide solution (0.1mol / L) to neutralize, then add a solvent to make up the volume, shake well, and you get it.

[0145] Acid destruction solution of cefotaxime reference substance: Weigh about 42mg of cefotaxime reference substance, weigh it accurately, place it in a 50mL volumetric flask...

Embodiment 3

[0294] Embodiment 3: Determination of sample measurement results and limits.

[0295] 1. Content determination of main impurities:

[0296] A series of methodological investigations were carried out on the impurity analysis method, and the results proved that the method has good system applicability and can effectively detect the two main impurities in cefotaxime sodium and tazobactam sodium for injection. The results of the determination of the impurity content in the 3 batches of samples are shown in Table 37.

[0297] Table 37. Determination results of main impurities

[0298]

[0299] According to the above-mentioned inspection results, combined with the cefotaxime sodium for injection in the 2010 edition of the Chinese Pharmacopoeia and the cefotaxime sodium impurity limit requirements and stability test results in the 8th edition of the European Pharmacopoeia, the impurity content limit is formulated: in the test solution In the chromatogram, deducting the blank sol...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

PUM

PropertyMeasurementUnit
wavelengthaaaaaaaaaa
Login to view more

Abstract

The invention belongs to the technical field of the pharmaceutical analysis, and particularly relates to a method for simultaneously measuring content of main components and main impurities in cefotaxime sodium tazobactam sodium for injection. The method comprises the following steps: using octadecyl silane bonded silica gel as filler of a chromatographic column, using mixed solution of phosphoricacid-phosphate buffer solution and methyl alcohol in a certain proportion as a flowing phase, simultaneously detecting the content of two main components and two main impurities in the cefotaxime sodium tazobactam sodium for injection, thereby effectively controlling quality of the cefotaxime sodium tazobactam sodium for injection. In addition, the invention further develops reference solution for positioning the known impurities. The reference solution is suitable for positioning a cefotaxime impurity B and impurity F in an HPLC detecting method, and improving pertinency of impurity detection. The method is strong in specificity, high in precision, good in stability, simple and convenient in operation, and strong in pertinency, an expensive impurity reference substance is prevented frombeing used, and the method has a good application value.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, in particular to a method for simultaneously determining the contents of main components and main impurities in cefotaxime sodium and tazobactam sodium for injection. Background technique [0002] Cefotaxime Sodium and Tazobactam Sodium for Injection is a compound preparation of Cefotaxime Sodium (CTX) and Tazobactam Sodium (Tazobactam Sodium, TAZ). Cefotaxime sodium (molecular formula C 16 h 16 N 5 o 7 S 2 Na, molecular weight is 477.45) is the third generation semi-synthetic cephalosporin, tazobactam sodium (molecular formula is C 10 h 11 N 4 o 5 SNa, with a molecular weight of 322.27) is a semi-synthetic β-lactamase inhibitor, and the combination of the two can enhance the antibacterial effect and broaden the antibacterial spectrum. [0003] [0004] At present, the pharmacopoeias of various countries only record the test methods for a single main component. Although this typ...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

Application Information

Patent Timeline
no application Login to view more
Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 袁耀佐张玫黄敏文王有志胡兰兰
Owner JIANGSU LINGBAO PHARMA
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Try Eureka
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap