Abstract
The cefuroxime sodium is a second generation cephalosporin indicated for infections caused by Gram-positive and Gram-negative microorganisms. Although this drug is highly studied and researched regarding the antimicrobial activity, pharmacokinetics and pharmacodynamics, there are few studies regarding the development of analytical methodology for this cephalosporin. Thus, research involving analytical methods is essential and highly relevant to optimize its analysis in the pharmaceutical industry and guarantee the quality of the product already sold. This study describes the development and validation of a microbiological assay applying the turbidimetric method for the determination of cefuroxime, using Micrococcus luteus ATCC 9341 as micro-organism test and 3x3 parallel line assay design, with nine tubes for each assay, as recommended by the Brazilian Pharmacopoeia. The developed and validated method showed excellent results of linearity, seletivity, precision and robustness, in the concentration range from 30.0 to 120.0 mg/mL, with 100.21% accuracy and content 99.97% to cefuroxime sodium in injectable pharmaceutical form.
Highlights
Cefuroxime {4-(carbamoxylomymethyl)-8-[2-2-furyl-2-methoxyimino-acetyl] amino -7-oxo-2-thia6-azabicyclo [4.2.0] oct-4-ene-5-carboxylic acid} (Figure 1) is an injectable second-generation β-lactam cephalosporin.Cefuroxime is structurally similar to other amino-thiazolyl methoxyimino third-generation cephalosporins, such as cefotaxime and ceftazidime [1]
Microbiological methods are used to determine the potency of antimicrobial agents and they play an essential role in the manufacturing processes and quality control of these drugs [27,28]
Considering that the turbidimetric assay has the advantage of reduced analysis time when compared to the agar diffusion method, where the analysis time is 24 h, the aim of this work was to propose a rapid turbidimetric method for the analysis of cefuroxime sodium’s potency in the dosage form of powder for dissolution for injection
Summary
Cefuroxime {4-(carbamoxylomymethyl)-8-[2-2-furyl-2-methoxyimino-acetyl] amino -7-oxo-2-thia6-azabicyclo [4.2.0] oct-4-ene-5-carboxylic acid} (Figure 1) is an injectable second-generation β-lactam cephalosporin.Cefuroxime is structurally similar to other amino-thiazolyl methoxyimino third-generation cephalosporins, such as cefotaxime and ceftazidime [1]. There are many physicochemical analytical methods described in the literature for the analysis of cefuroxime in different matrices, using techniques such as HPLC [16,17,18,19,20,21], fluorimetry [22], spectrophotometry [23,24,25] and chemiluminescence [26]. Despite this fact, physicochemical methods used to quantify antimicrobial agents, accurate, are not able to indicate the true biological activity of the drug. Considering that the turbidimetric assay has the advantage of reduced analysis time when compared to the agar diffusion method, where the analysis time is 24 h, the aim of this work was to propose a rapid turbidimetric method for the analysis of cefuroxime sodium’s potency in the dosage form of powder for dissolution for injection
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