Stability-indicating LC method for the determination of cephalothin in lyophilized powder for injection

Rugani, Karen de Souza; Salgado, Hérida Regina Nunes

doi:10.1039/c3ay42049c

Cited by 9 publications

(3 citation statements)

References 20 publications

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“…The validation parameters for linearity, specificity, precision, accuracy, robustness, limit of detection (LOD) and limit of quantification (LOQ) was according to the parameters established in guidelines (17,18,(22)(23)(24)(25)(26)(27)(28).…”

Section: Methods Validationmentioning

confidence: 99%

Development and Validation of an Ecological, New and Rapid Stability-Indicating High Performance Liquid Chromatography for Quantitative Determination of Aztreonam in Lyophilized Powder for Injection

2017

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Aztreonam is a monocyclic synthetic antimicrobial with bactericidal activity against Gram-negative bacteria, the first agent from the monobactam family to be therapeutically approved. It was developed and validated analytical method using high performance liquid chromatography with UV detection at 292 nm to quantify the aztreonam. Furthermore, assessing stability through stress tests was carried out. The chromatographic separation was carried out by reverse phase on an Agilent C18 column (250 x 4.6 mm, 5 µm) with a mobile phase composed of water:ethanol (70:30, v/v) adjusted to pH 2.5 with acetic acid, pumped isocratically at a flow rate of 0.5 mL/min. The validation parameters linearity, selectivity, precision, accuracy, robustness, limits of detection and quantification were determined. The method proposed provides linear response within the concentration range of 45-95 µg/mL for aztreonam. Results obtained were found to be satisfactory. The proposed method is linear, accurate, precise, selective, and robust being able to quantify the aztreonam in raw material and in pharmaceutical preparations. The validated method was suitable for applications in quality control laboratories.

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Section: Methods Validationmentioning

confidence: 99%

Development and Validation of an Ecological, New and Rapid Stability-Indicating High Performance Liquid Chromatography for Quantitative Determination of Aztreonam in Lyophilized Powder for Injection

2017

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“…It is a separation technique and there are many possibilities of mobile phases, stationary phases and detectors, which permit an excellent selectivity and analysis of different compounds simultaneously. Among the methods for the drug in literature, the majority use buffer solution in the mobile phase, with consequent precipitation in the equipment and chromatographic column over time, reducing their life time and improving the analysis cost Salgado, 2008, 2012;Pedroso and Salgado, 2014;Rugani and Salgado, 2014).…”

Section: -30mentioning

confidence: 99%

A Critical Review of Analytical Methods for Quantification of Cefotaxime

Consortti

Salgado

2017

Critical Reviews in Analytical Chemistry

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Bacterial resistance to antibiotics is a growing phenomenon in the world. Considering the relevance of antimicrobials for population and the reduction in the registration of new antimicrobials by regulatory, proper quality control is required in order to minimize the spread of bacterial resistance and ensure the effectiveness of a treatment, as well as safety for the patient. Among the antimicrobials is cefotaxime, a drug belonging to third-generation cephalosporins, which is highly active against Gram-negative bactéria and is used to treat central nervous system infections such as meningitis and septicemia. Due to the critical importance of quality control in regard to drugs and pharmaceutical products, combined with bacterial resistance to antibiotics, this study aims to conduct a detailed review of analytical methods for cefotaxime. Using a critical review of literature, this paper describes the analytical methods published to quantify cefotaxime in different matrices; a large number of methods by HPLC and spectrophotometry were observed. Despite the advantages of the techniques, most methods reported have large environment and occupational impact, which enfatizes the need to adopt green procedures in quantifying cefotaxime.

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“…Chromatographic methods prioritizing shorter analyses that are economically viable, reduce the quantities of waste to the environment, and are safer for the analyst, are of great importance and have gained prominence (Bonfilio et al, 2009;Lopes, Salgado, 2009;Moreno, Salgado, 2008;Pedroso, Salgado, 2014;Rugani, Salgado, 2014;Silva, Salgado, 2012;Tótoli, Salgado, 2014;Vieira, Salgado, 2011).…”

Section: Introductionmentioning

confidence: 99%

Stability-indicating RP-LC method for quantification of fusidic acid in cream

Curbete

Salgado

2016

Braz. J. Pharm. Sci.

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Fusidic acid is an antibiotic steroid indicated for the treatment of infections caused by the genus Staphylococcus, including methicillin resistant Staphylococcus aureus strains, and other Gram-positive bacteria. In the present study, a stability-indicating reversed-phase liquid chromatography (RP-LC) method was developed and validated for the determination of fusidic acid in dermatological cream as an alternative to existing methods. Analyses were performed using a C 18 column and guard column at room temperature, eluting with an isocratic mobile phase of acetonitrile and water (72:28, v/v), adjusted to pH 3.5 with acetic acid, pumped at a flow rate of 1.0 mL min -1 , detection at 210 nm and 20 µL of injection volume. The forced degradation study was conducted under acidic, alkaline, neutral, photolytic, and oxidative stress conditions. The method was validated according to ICH and FDA guidelines; it was linear, precise, accurate, selective, and robust over concentrations of 5-95 µg mL , respectively. Therefore, we conclude that this method is suitable for quantifying fusidic acid in pharmaceutical dermatological creams and determining its stability, representing a more economical and practical alternative for routine analysis in quality control. Uniterms:Fusidic acid/stability-indicating/quality control/validation. Chromatography/reversed-phase.

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Stability-indicating LC method for the determination of cephalothin in lyophilized powder for injection

Abstract: A stability-indicating gradient reversed phase liquid chromatography (RP-LC) method has been developed for the quantitative determination of cephalothin (CET), an antimicrobial compound, in the presence of its impurities and degradation products generated from forced degradation studies.

Cited by 9 publications

References 20 publications

Development and Validation of an Ecological, New and Rapid Stability-Indicating High Performance Liquid Chromatography for Quantitative Determination of Aztreonam in Lyophilized Powder for Injection

Development and Validation of an Ecological, New and Rapid Stability-Indicating High Performance Liquid Chromatography for Quantitative Determination of Aztreonam in Lyophilized Powder for Injection

A Critical Review of Analytical Methods for Quantification of Cefotaxime

Stability-indicating RP-LC method for quantification of fusidic acid in cream

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