Development and validation of a simultaneous extraction procedure for HPLC-MS quantification of daptomycin, amikacin, gentamicin, and rifampicin in human plasma

Baietto, Lorena; D’Avolio, Antonio; Rosa, Francesco Giuseppe De; Garazzino, Silvia; Michelazzo, M.; Ventimiglia, Giusi; Siccardi, Marco; Simiele, Marco; Sciandra, Mauro; Perri, Giovanni Di

doi:10.1007/s00216-009-3263-1

Cited by 69 publications

(51 citation statements)

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“…1, which has four primary amine groups, one secondary amine group, one primary OH group and seven secondary OH groups [10]. Direct UV methods are not available in literature because the drug is not absorbing in the UV region.…”

Section: Fig 1: Amikacin Chemical Structurementioning

confidence: 99%

Spectrophotometric Method for the Determination Amikacin in Pure and Pharmaceutical Dosage Form

Teja

Gurupadayya

Sairam

2018

Int J Curr Pharm Sci

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Objective: The aim of the study was to develop an easy, sensible and rapid method for the estimation of amikacin in both pure and marketed formulation using the spectrophotometric method.Methods: Due to lack of chromophoric group in the amikacin, it was derivatized with 0.1 mmol chloranillic acid reagent. For the estimation of amikacin, Shimadzu UV-1700 model spectrophotometer with UV probe software was used. The method was based on simple charge transfer complexation of the drug with a p-chloranillic acid reagent to give a purple coloured product which was measured at 524nm against blank solution. Results:The derivatised product of amikacin was detected at a wavelength of 524 nm. Linearity was observed with the concentration range of 20-100 µg/ml with a regression coefficient of 0.9803. Results of all the parameters were within the acceptance criteria with % RSD less than 2. Conclusion:The spectroscopic method was validated as per ICH guidelines and was found to be applicable for routine quantitative analysis of amikacin in marketed formulations also. The results of linearity, precision, accuracy LOD and LOQ were within the specified limits. The method is highly sensitive, robust, reproducible and specific.

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Section: Fig 1: Amikacin Chemical Structurementioning

confidence: 99%

Spectrophotometric Method for the Determination Amikacin in Pure and Pharmaceutical Dosage Form

Teja

Gurupadayya

Sairam

2018

Int J Curr Pharm Sci

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“…Most of these studies are directed towards biological fluid analysis by high performance liquid chromatography (HPLC), (Tobin et al, 2008;Martens-Lobenhoffer et al, 2008;Baietto et al, 2010;Gika et al, 2010;Olszowy et al, 2010;Polillo et al, 2010;Verdier et al, 2011;Szultka et al, 2013) and ultra-performance liquid chromatography (UHPLC) (Gikas et al, 2010a; Gikas et al, 2010b; Bazoti et al, 2011;Baietto et al, 2014;Naito et al, 2014). In addition, there are no monographs of this drug in any official compendium.…”

Section: Introductionmentioning

confidence: 99%

A green approach for the quantification of daptomycin in pharmaceutical formulation by UV spectrophotometry

Tótoli

Salgado

2015

Braz. J. Pharm. Sci.

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Daptomycin is the first approved drug from a new class of antimicrobials, the cyclic lipopeptides, and is a very important antimicrobial agent in current clinical practice. Currently, there are no "green" analytical methods described in the literature to analyze the typical pharmaceutical dosage form of daptomycin. Thus, the aim of this work was to validate an environment-friendly spectrophotometric method in the UV region, for the analysis of daptomycin as a lyophilized powder. Water was used as diluent and the analyses were carried out on a spectrophotometer at 221 nm. The method met all validation requirements of the ICH guidelines, over a concentration range of 6-21 µg mL -1 . A Student's t-test demonstrated that the proposed method was comparable to an HPLC method previously validated. Thus, the validated spectrophotometric method could quantify daptomycin in a powder form for injectable solutions, while being an economical, rapid, and "green" alternative for routine analysis in quality control.Uniterms: Antimicrobials/quality control. Daptomycin/determination. Spectrophotometry/UV region/ quantitative analysis. Spectrophotometry/green analytical method.A daptomicina é o primeiro membro aprovado de uma nova classe de antimicrobianos, os lipopeptídeos cíclicos, e é muito importante para a prática clínica atualmente. Não existem métodos analíticos "verdes" descritos na literatura para a análise da daptomicina na forma farmacêutica. Desta forma, o objetivo deste trabalho foi a validação de método espectrofotométrico na região do UV ambientalmente favorável para análise da daptomicina em pó liofilizado. A água foi escolhida como diluente e as análises foram realizadas em 221 nm. O método atendeu a todas as exigências de validação dos guias do ICH, na faixa de 6-21 µg mL -1 . Teste t de Student mostrou que o método proposto é intercambiável com método de HPLC previamente validado. Assim, o método espectrofotométrico validado é capaz de quantificar a daptomicina em pó para solução injetável e é uma opção econômica, rápida e "verde" para análises de rotina do controle de qualidade deste fármaco.Unitermos: Antimicrobianos/controle de qualidade. Daptomicina/determinação. Espectrofotometria/ região do UV/análise quantitativa. Espectrofotometria/método analítico verde. INTRODUCTIONIt is widely known that microbial resistance is a major problem worldwide. Many bacteria have developed resistance to a large number of antimicrobial agents available on the market; these bacteria are considered challenges for medicine. Methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin resistant enterococci (VRE) are two examples of antimicrobialresistant microorganisms (Silveira et al., 2006;Wright, 2011). Compounding the problem of antimicrobial resistance, there are few new antimicrobial agents emerging in the market (Wright, 2011).One recent development in antimicrobial treatment is the introduction of daptomycin into the marketplace (Figure 1). This is the first antimicrobial agent from the cyclic lipopeptide class appro...

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“…The action mechanism is physiologic calcium dependent and possibly involves the disruption of amino acid transport by the cell membrane and changes in the cytoplasmic membrane potential (Debono et al, 1987;Koeth, Thorne, 2010;Lu et al, 2011). Some LC methods have been reported in the literature in order to determine DPT in some biological fluids, such as serum (Deryke et al, 2006;Rybak et al, 1992;Tobin et al, 2008), blood (Gikas et al, 2009;Olszowy et al, 2010), and plasma (Baietto et al, 2010;Dvorchik et al, 2003;Martens-Lobenhofer et al, 2008;Verdier et al, 2011). Recently, an HPLC method focusing on the assay of daptomycin injection was reported, which is the only pharmaceutical form available (Christ et al, 2014).…”

Section: Introductionmentioning

confidence: 99%

A fully validated microbiological assay for daptomycin injection and comparison to HPLC method

Christ

Machado

Ribas

et al. 2015

Braz. J. Pharm. Sci.

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Daptomycin (DPT) was the first lipopeptide antibiotic available for commercialization. It is active against gram-positive bacteria, including resistant strains. This work aimed to develop and validate a turbidimetric microbiologic assay to determine daptomycin in an injectable form. A 3x3 design was employed, at concentrations of 1, 2 and 4.0 µg/mL. The microorganism test used was Staphylococcus aureus ATCC 6538p, and Antibiotic Medium 3 was used as the culture medium. Method validation demonstrated that the bioassay was linear (r=0.9995), precise (RSD=2.58%), accurate (recovery 100.48± 2.11%), and robust. Degradation kinetics was also performed in an alkaline medium, indicating that daptomycin degradation follows first order kinetics under these conditions. The analyses of degraded solutions showed that daptomycin degradation products do not possess bactericidal activity. The bioassay was compared to HPLC method that was previously developed and no significant difference was found between them (p>0.05). The method proved to be appropriate for daptomycin injection quality control.Uniterms: Daptomycin/determination. Daptomycin injection/quality control. Turbidimetric microbiological assay/quantitative analysis.A daptomicina (DPT) é o primeiro lipopeptídeo cíclico disponível para comercialização. Possui atividade frente a bactérias gram-positivas, incluindo cepas resistentes. O objetivo deste trabalho foi desenvolver e validar um ensaio microbiológico turbidimétrico para quantificar a daptomicina na forma injetável. Empregou-se delineamento 3x3, nas concentrações de 1,0; 2,0 e 4,0 µg/mL. Como micro-organismo teste foi usado Staphylococcus aureus ATCC 6538p, e Meio para Antibióticos nº 3 foi empregado como meio de cultura. A validação do método demonstrou que o ensaio foi linear (r=0,9995), preciso (RSD=2,55%), exato (recuperação de 100,48 ± 2,11%) e robusto. A cinética de degradação em meio alcalino foi avaliada, indicando que a daptomicina segue cinética de primeira ordem nessa condição. A análise das soluções degradadas mostrou que os produtos de degradação da daptomicina não possuem atividade antimicrobiana. O bioensaio foi comparado com o método por CLAE previamente desenvolvido e não houve diferença significativa entre ambos (p<0,05). O método mostrou-se apropriado para o controle de qualidade da daptomicina injetável.Unitermos: Daptomicina/determinação. Daptomicina injetável/controle de qualidade. Ensaio microbiológico turbidimétrico/análise quantitativa.

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Development and validation of a simultaneous extraction procedure for HPLC-MS quantification of daptomycin, amikacin, gentamicin, and rifampicin in human plasma

Cited by 69 publications

References 40 publications

Spectrophotometric Method for the Determination Amikacin in Pure and Pharmaceutical Dosage Form

Spectrophotometric Method for the Determination Amikacin in Pure and Pharmaceutical Dosage Form

A green approach for the quantification of daptomycin in pharmaceutical formulation by UV spectrophotometry

A fully validated microbiological assay for daptomycin injection and comparison to HPLC method

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