Hydrophilic interaction chromatography/tandem mass spectrometry for the simultaneous determination of three polar non‐structurally related compounds, imipenem, cilastatin and an investigational <i>β</i>‐lactamase inhibitor, MK‐4698, in biological matrices

Xu, Yang; Xie, Weiping; Miller‐Stein, Cynthia; Woolf, Eric

doi:10.1002/rcm.4138

Cited by 14 publications

(12 citation statements)

References 19 publications

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“…A large diversity of pharmaceutical compounds, belonging to different therapeutical classes, has been analyzed in HILIC mode using bare‐silica as SP 21–52. Both non‐biological 27, 31, 35, 36, 38, 41, 44, 51 and biological 21–26, 28–30, 32–34, 37, 39, 40, 42, 43, 45–50, 52 assays are described. The finally reported experimental conditions are presented in Table 1.…”

Section: Pharmaceutical Applicationsmentioning

confidence: 99%

HILIC methods in pharmaceutical analysis

Dejaegher

Heyden

2010

J of Separation Science

172

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In this review, hydrophilic interaction liquid chromatographic (HILIC) applications for pharmaceutical analysis are discussed. The HILIC technique uses an aqueous/organic modifier mobile phase with a high organic modifier fraction and a hydrophilic stationary phase (SP). In general, the SPs are silica or polymer based. The silica-based columns are most often applied and are divided into bare-silica particle, chemically bonded silica particle, and monolithic phases. The bare-silica columns are most frequently used. The much less applied polymer-based columns are also divided into particle and monolithic phases. In this review, the applications are grouped and discussed according to the SP type used. Whenever possible, the considered HILIC application is compared with other HILIC methods, e.g. on other SPs, and/or with other separation modes, for that application. The advantages and drawbacks of HILIC are also discussed, as well as the method validation issues, when executed.

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Section: Pharmaceutical Applicationsmentioning

confidence: 99%

HILIC methods in pharmaceutical analysis

Dejaegher

Heyden

2010

J of Separation Science

172

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“…Imipenem (2 g daily, 0.5 hour infusion of 0.5 g every 6 to 8 hours) provides sufficient drug exposure in the pediatric burn patients investigated in the present study according to data reported previously in critically ill adult patients (Dailly et al, 2003;Xu et al, 2009).…”

Section: Therapeutic Drug Monitoringmentioning

confidence: 52%

“…Several drug measurements have been reported previously for imipenem in biological matrices by applying microbiological techniques (Pietroski et al, 1991) and chromatographic methods such as LC-UV (Buckley et al, 1992;Belzeberg et al, 2004;Ebey, Boucher, Pieper, 1988;Garcia-Capdevila et al, 1997;Gravallese et al, 1984;Kurihara, Kizu, Hori, 2008;Legrand et al, 2008;) and LC-MS/MS (Xu et al, 2009). With regard to the drug assay for imipenem dose adjustment, LC-UV was preferred by its relative low cost relative to routine LC/MS/MS drug plasma measurements.…”

Section: Methodsmentioning

confidence: 99%

“…A survey of the literature has revealed several analytical methods to determine imipenem in biological fluids using high-cost procedures, including LC-MS/ MS (Xu et al, 2009) and capillary zone electrophoresis (Taniguchi et al, 1999) or methods that rely on low-cost and very simple microbiological assays with quite low specificities (Pietroski et al, 1991).…”

Section: Introductionmentioning

confidence: 99%

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Pharmacokinetic-pharmacodynamic correlation of imipenem in pediatric burn patients using a bioanalytical liquid chromatographic method

Santos

Sanches

Júnior

et al. 2015

Braz. J. Pharm. Sci.

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A bioanalytical method was developed and applied to quantify the free imipenem concentrations for pharmacokinetics and PK/PD correlation studies of the dose adjustments required to maintain antimicrobial effectiveness in pediatric burn patients. A reverse-phase Supelcosil LC18 column (250 x 4.6 mm 5 micra), binary mobile phase consisting of 0.01 M, pH 7.0 phosphate buffer and acetonitrile (99:1, v/v), flow rate of 0.8 mL/min, was applied. The method showed good absolute recovery (above 90%), good linearity (0.25-100.0 µg/mL, r 2 =0.999), good sensitivity (LLOQ: 0.25 µg/mL; LLOD: 0.12 µg/mL) and acceptable stability. Inter/intraday precision values were 7.3/5.9%, and mean accuracy was 92.9%. A bioanalytical method was applied to quantify free drug concentrations in children with burns. Six pediatric burn patients (median 7.0 years old, 27.5 kg), normal renal function, and 33% total burn surface area were prospectively investigated; inhalation injuries were present in 4/6 (67%) of the patients. Plasma monitoring and PK assessments were performed using a serial blood sample collection for each set, totaling 10 sets. The PK/PD target attained (40%T>MIC) for each minimum inhibitory concentration (MIC: 0.5, 1.0, 2.0, 4.0 mg/L) occurred at a percentage higher than 80% of the sets investigated and 100% after dose adjustment. In conclusion, the purification of plasma samples using an ultrafiltration technique followed by quantification of imipenem plasma measurements using the LC method is quite simple, useful, and requires small volumes for blood sampling. In addition, a small amount of plasma (0.25 mL) is needed to guarantee drug effectiveness in pediatric burn patients. There is also a low risk of neurotoxicity, which is important because pharmacokinetics are unpredictable in these critical patients with severe hospital infection. Finally, the PK/PD target was attained for imipenem in the control of sepsis in pediatric patients with burns.Uniterms: Imipenem/quantification. Antibiotics/dosage. Pediatric patients/burn/antibiotics use. High Performance Liquid Chromatography/quantitative analysis. Drug plasma monitoring. PK/PD.Desenvolveu-se e aplicou-se método bioanalítico para quantificar concentrações de imipenem livre para estudos de farmacocinética (PK) e de correlação PK/PD dos ajustes de dose requeridos para manter a efetividade antimicrobiana em pacientes pediátricos queimados. Utilizou-se coluna Supelcosil LC18 (250 x 4,6 mm 5 micra), fase móvel binária, consistindo de tampão fosfato 0,01M pH 7,0 e acetonitrila (99:1, v/v) e fluxo de 0,8 mL/min. O método mostrou boa recuperação absoluta (acima de 90%), boa linearidade (0,25-100,0 µg/mL, r 2 =0.999), boa sensibilidade (LLOQ: 0,25 µg/mL; LLOD: 0,12 µg/mL) e estabilidade aceitável. Os valores de precisão inter/intradia foram 7,3/5,9% e a exatidão média foi de 92,9%. O método bioanalítico foi aplicado para quantificar concentrações de fármaco livre em crianças com queimaduras, Seis pacientes pediátricos queimados (idade média de 7,0 anos, 27,5 kg), com função renal n...

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“…It has been widely used for retaining very polar organic molecules that may not be retained by RP columns [8]. Unlike the highly aqueous mobile phases required for polar molecule retention in RP separations, HILIC conditions employ high percentages of organic solvent in the mobile phase, which is ideal for optimizing mass spectrometric sensitivity [9].…”

Section: Chromatographymentioning

confidence: 99%