Analysis of 12 beta-lactam antibiotics in human plasma by HPLC with ultraviolet detection

McWhinney, Brett; Wallis, Steven C.; Hillister, Tara; Roberts, Jason A.; Lipman, Jeffrey; Ungerer, Jacobus P.J.

doi:10.1016/j.jchromb.2010.05.027

Cited by 184 publications

(143 citation statements)

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“…For a comprehensive review of advances in the determination of -lactam antibiotics by liquid chromatography using different detector systems, the reader is referred to the paper by Lara et al [44]. In general, a number of HPLC methods with ultraviolet detection are described for -lactams including simultaneous determination of several -lactams [45][46][47][48][49].…”

Section: Page 8 Of 48mentioning

confidence: 99%

“…The primary stocks were then diluted with water to give 5 mg/mL standard solutions for each antibiotic and were stored in 1 mL aliquots at -80 °C under which condition -lactams are known to be stable at least for few months [45,46,50,51]. These standard solutions were used to prepare fresh standards and QCs in plasma for every analytical run.…”

Section: Preparation Of Solutions Standards and Quality Control Sammentioning

confidence: 99%

“…It allowed a simple and efficient protein extraction process with excellent analyte recoveries. Protein precipitation using acetonitrile alone [68], acetonitrile followed by formic acid [51] or organic extraction [69] has been described earlier for -lactam antibiotics. Acetonitrile is one of the most efficient protein precipitants particularly at precipitant to plasma volume ratios of 2 : 1 or greater and has excellent reproducibility.…”

Section: Analysis Of Patient Samplesmentioning

confidence: 99%

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Simultaneous determination of seven β-lactam antibiotics in human plasma for therapeutic drug monitoring and pharmacokinetic studies

Sime

Roberts

et al. 2014

Journal of Chromatography B

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This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. AbstractThere is strong evidence in literature supporting the benefit of monitoring plasma concentrations of -lactam antibiotics in the critically ill to ensure appropriateness of dosing.The objective of this work was to develop a method for the simultaneous determination of total concentrations piperacillin, benzylpenicillin, flucloxacillin, meropenem, ertapenem, cephazolin and ceftazidime in human plasma. Sample preparation involved protein precipitation with acetonitrile containing 0.1% formic acid and subsequent dilution of supernatant with 0.1% formic acid in water. Chromatographic separation was achieved on a reversed phase column (C18, 2.6µm, 2.1* 50 mm) via gradient elution using water and acetonitrile, each containing 0.1% formic acid, as mobile phase. Tandem mass spectrometry (MSMS) analysis was performed, after electrospray ionization in the positive mode, with multiple reaction monitoring (MRM). The method is accurate with the inter-day and intra-day accuracies of quality control samples (QCs) ranging from 95%-107% and 95%-108%, respectively. It is also precise with intra-day and inter-day coefficient of variations ranging from 4 to 12 % and 5-14% respectively. The lower limit of quantification was 0.1g/mL for each antibiotic except flucloxacillin (0.25g/mL). Recovery was greater than 96% for all analytes except for ertapenem (78%). Coefficients of variation for the matrix effect were less than 10% over the six batches of plasma. Analytes were stable over three freeze-thaw cycles, and for reasonable hours on the bench top as well as post-preparation. This novel liquid chromatography tandem mass spectrometry method proved accurate, precise and applicable for therapeutic drug monitoring and pharmacokinetic studies of the selected -lactam antibiotics.Page 5 Highlights  We present a method for simultaneous determination of seven beta-lactams in plasma  The selected antibiotics are those commonly used in critically ill patients  The method is accurate, precise and meets validation requirements by guidelines  It proved applicable for therapeutic drug monitoring and pharmacokinetic studies

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Section: Page 8 Of 48mentioning

confidence: 99%

Section: Preparation Of Solutions Standards and Quality Control Sammentioning

confidence: 99%

Section: Analysis Of Patient Samplesmentioning

confidence: 99%

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Simultaneous determination of seven β-lactam antibiotics in human plasma for therapeutic drug monitoring and pharmacokinetic studies

Sime

Roberts

et al. 2014

Journal of Chromatography B

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“…To assess the concentration of CFTX in biological matrices such as plasma, serum, cerebrospinal fluid and bile, several physicochemical methods have been reported, such as HPLC (Patel et al, 1981;Trautmann, Haefelfinger, 1981;Ascalone, Dal Bò, 1983;Bowman et al, 1984;Chan et al, 1986;Granich, Krogstad, 1987;Bompadre et al, 1998;Kohlhepp et al, 1998;Tsai et al, 1999;Nemutlu et al, 2009;Mcwhinney et al, 2010), spectrofluorometric assays (Omar et al, 2009), and capillary zone electrophoresis (CZE) (Quaglia et al, 1997). Microbiological techniques are used to evaluate the bioavailability of CFTX in biological fluids (Rebuelto et al, 2002;Ismail et al, 2005) and to study the susceptibility of several microorganisms to CFTX (Beskid et al, 1981;Eickhoff, Ehret, 1981;Baumgartner, Glauser, 1983;Emmerson et al, 1985;Dias et al, 1998).…”

Section: Introductionmentioning

confidence: 99%

A fully validated microbiological assay to evaluate the potency of ceftriaxone sodium

Manfio

Agarrayua

Machado

et al. 2013

Braz. J. Pharm. Sci.

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Ceftriaxone (CFTX) sodium is a third-generation, broad-spectrum cephalosporin that is resistant to betalactamases. An alternative bioassay for the assessment of the potency of this drug in pharmaceutical formulations has not been previously reported. Thus, this paper reports the development and full validation of a 3 x 3 agar diffusion bioassay using a cylinder-plate method to quantify CFTX sodium in pharmaceutical samples. The strain Staphylococcus aureus ATCC 6538P was used as the test microorganism, and the results of the proposed bioassay displayed high linearity, precision, accuracy, specificity and robustness. All potency results were statistically analyzed using an analysis of variance (ANOVA) and were found to be linear (r=0.99999) in the range of 16-64 μg/mL, accurate (100.5%), and precise [repeatability: relative standard deviation (RSD)=1.4%; intermediate precision: between-day RSD=2.1% and between-analyst RSD=2.5%]. The specificity of the bioassay was determined by evaluating a degraded sample (50 ºC) at 0, 24 and 48 hours as compared against the results from the pharmacopeial liquid chromatography method for CFTX. The results validated the proposed microbiological assay, which allows reliable quantitation of CFTX in pharmaceutical samples. Moreover, it is a useful, simple and low-cost alternative method for monitoring the quality of this medicine.Uniterms: Ceftriaxone/agar diffusion assay. Ceftriaxone/quality control. Ceftriaxone/microbiological assay. Drugs/quality control.A ceftriaxona sódica é uma cefalosporina de terceira geração de uso parenteral, com amplo espectro de atividade e resistente a b-lactamases. Este estudo apresenta o desenvolvimento e validação de um bioensaio por difusão em ágar usando o método de cilindros em placas para determinação da potência deste antibiótico. A validação desenvolvida apresentou bons resultados em termos de linearidade, precisão, exatidão, especificidade e robustez. Empregou-se o Staphylococcus aureus ATCC 6538P como micro-organismo teste. Os resultados dos ensaios foram tratados estatisticamente utilizando-se análise de variância (ANOVA). O método apresentou linearidade (r=0,99999) na faixa de doses selecionada (16-64 µg/mL), precisão (repetibilidade: DPR=1,4%; precisão intermediária: inter-dias DPR=2,1% e inter-analistas: DPR=2,5%) e exatidão de 100,5%. A especificidade do bioensaio foi avaliada através da análise comparativa, por cromatografia líquida de alta eficiência, de amostras degradadas a 50 ºC nos tempos zero, 24 e 48 h. Os resultados encontrados demonstraram a validade do bioensaio proposto, o qual permite a quantificação confiável de ceftriaxona sódica em produtos farmacêuticos comerciais. Por ser metodologia simples e de baixo custo constitui-se em alternativa para a análise de rotina do controle de qualidade de medicamentos.Unitermos: Ceftriaxona/ensaio de difusão em ágar. Ceftriaxona/controle de qualidade. Ceftriaxona/ ensaio microbiológico. Fármacos/controle de qualidade.

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“…14 Meropenem (MRPM) has been determined in human plasma [15][16][17][18] and serum concentration 19 by high-performance liquid chromatography (HPLC) with ultraviolet detection and RP-HPLC in pharmaceutical dosage forms. 20 Imipenem (IMPM) was determined in serum and human plasma, respectively, by HPLC 19,20 and RP-HPLC in human urine serum.…”

Section: Introductionmentioning

confidence: 99%

Chromatographic Separation Studies of Penicillins, Cephalosporins and Carbapenems on Transition-Metal Silicate Modified Silica Layers

Singh

Maheshwari

2012

ANAL. SCI.

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Analysis of 12 beta-lactam antibiotics in human plasma by HPLC with ultraviolet detection

Cited by 184 publications

References 12 publications

Simultaneous determination of seven β-lactam antibiotics in human plasma for therapeutic drug monitoring and pharmacokinetic studies

Simultaneous determination of seven β-lactam antibiotics in human plasma for therapeutic drug monitoring and pharmacokinetic studies

A fully validated microbiological assay to evaluate the potency of ceftriaxone sodium

Chromatographic Separation Studies of Penicillins, Cephalosporins and Carbapenems on Transition-Metal Silicate Modified Silica Layers

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