Validation of analytical methodology for quantification of cefazolin sodium pharmaceutical dosage form by high performance liquid chromatography to be applied for quality control in pharmaceutical industry

Pedroso, Tahisa Marcela; Salgado, Hérida Regina Nunes

doi:10.1590/s1984-82502011000100022

Cited by 11 publications

(4 citation statements)

References 19 publications

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“…For a method to be considered robust, the absolute values of the effects must be less than the critical value (√2 S ) (Pedroso & Salgado, 2014).…”

Section: Methodsmentioning

confidence: 99%

Development and validation of method for the simultaneous determination of sulfamethazine, trimethoprim and doxycycline in veterinary formulation using high performance liquid chromatography

dos Santos,

do Amaral,

Fernando Mazon Cardoso

et al. 2023

Biomedical Chromatography

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Sulfamethazine (SMZ), trimethoprim (TMP) and doxycycline (DOXY) are drugs of choice used in the treatment of intestinal and respiratory infections that affect poultry and swine. The aim of this study was develop and validate a simple, sensitive and fast method for the simultaneous determination of SMZ, TMP and DOXY in veterinary formulations by high‐performance liquid chromatography. The separation was performed on a Macherey–Nagel C8 analytical column (4 × 125 mm, 5 μm), with a flow rate of 0.5 ml min−1 and detection at 268, 270 and 350 nm, for SMZ, TMP and DOXY, respectively. All measurements were performed in acetonitrile–water (45:55 v/v; pH 3.0). The analytical curves were linear (r > 0.9997) in the concentration range of 5.0–35.0 μg ml−1 for SMZ, 1.0–7.0 μg ml−1 for TMP and 7.0–13.0 μg ml−1 for DOXY. The method proved to be precise, robust, accurate and selective. In accelerated stability, the sample was analyzed for 6 months, with no major variations observed in organoleptic analysis and pH. Therefore, the developed method was proved to be suitable for routine quality control analyses for the simultaneous determination of SMZ, TMP and DOXY in pharmaceutical formulations.

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“…For a method to be considered robust, the absolute values of the effects must be less than the critical value (√2 S ) (Pedroso & Salgado, 2014).…”

Section: Methodsmentioning

confidence: 99%

Development and validation of method for the simultaneous determination of sulfamethazine, trimethoprim and doxycycline in veterinary formulation using high performance liquid chromatography

dos Santos,

do Amaral,

Fernando Mazon Cardoso

et al. 2023

Biomedical Chromatography

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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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“…10 Cefazolin sodium has some analytical methods described in official compendia such as British, 11 European, 12 Japanese, 13 Portuguese 14 and US 15 pharmacopeias. In the literature, several methods have been described for the qualitative 16 and quantitative analysis of cefazolin sodium, included spectrophotometry, [17][18][19][20][21][22][23][24][25][26][27][28][29] high-performance liquid chromatography [30][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46][47] and voltammetry. 48 However, most of them were time-consuming and dedicated to sophisticated and expensive analytical instruments.…”

Section: Introductionmentioning

confidence: 99%

New Environmentally Friendly Method for Quantification of Cefazolin Sodium

Rechelo¹,

Fernandes²,

Kogawa³

et al. 2017

ECB

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Cefazolin sodium, a β-lactam antimicrobial agent belonging to the first generation cephalosporins, has a broad spectrum of action, acting against gram positive and gram negative bacteria. Stands out over other cephalosporins for its ability to also act against some species of Enterobacter, and have a long half-life, thus reducing the frequency of administrations. A simple, fast and reproducible method by visible spectrophotometry was developed and validated for quantification of cefazolin sodium in the lyophilized powder. This technique is widely used in the pharmaceutical industry due to its ease of execution, low cost, safety and high precision and accuracy. It has been employed in the quality control routine of numerous pharmaceuticals in order to identify them and quantify their active principles. The method was capable of detecting and quantifying the cefazolin sodium obtaining satisfactory results regarding selectivity, precision, accuracy and robustness, on linear range of 32.0 to 92.0 µg mL -1 , showing the correlation coefficient of 0.9993 when analyzed at 767 nm. Due to the environmental impacts caused by global economic development, green chemistry has come up with a proposal to minimize and/or eliminate the use of harmful solvents, which generate large amounts of toxic waste to the environment and the health of operators, as well as reducing expenses with costly processes. The proposed method does not use toxic solvent, proving to be effective, low cost, easy to apply and safe for the analyst and environment. *Corresponding AuthorsFax: +55 16 3301 6967 E-Mail: ac_kogawa@yahoo.com.br [a]

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Validation of analytical methodology for quantification of cefazolin sodium pharmaceutical dosage form by high performance liquid chromatography to be applied for quality control in pharmaceutical industry

Cited by 11 publications

References 19 publications

Development and validation of method for the simultaneous determination of sulfamethazine, trimethoprim and doxycycline in veterinary formulation using high performance liquid chromatography

Development and validation of method for the simultaneous determination of sulfamethazine, trimethoprim and doxycycline in veterinary formulation using high performance liquid chromatography

A Critical Review of Analytical Methods for Quantification of Cefotaxime

New Environmentally Friendly Method for Quantification of Cefazolin Sodium

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