A new simple HPLC assay for the quantification of ertapenem in human plasma, lung tissue, and broncho-alveolar lavage fluid

Mundkowski, Ralf G.; Majcher-Peszynska, Jolanta; Burkhardt, Olaf; Welte, Tobias; Drewelow, Bernd

doi:10.1016/j.jchromb.2006.01.005

Cited by 18 publications

(13 citation statements)

References 12 publications

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“…7,9,10,25 Eighty-two samples of patients assuming ertapenem at the standard dosage of 1 g/daily have been analyzed; the lowest and the highest values of plasma ertapenem concentrations were 0.26 mg/mL and 149.7 mg/mL, respectively. The range of concentrations observed confirm the suitability of the calibration curve and the utility of our method for pharmacokinetic studies, in contrast with previously published methods, 14,15,18,21 which had limited concentration linearity.…”

Section: Discussionsupporting

confidence: 74%

“…[13][14][15]18,[21][22][23][24] A common feature of these methods is the lack of an IS. In this article, we describe a new HPLCultraviolet method for the determination of ertapenem in human plasma; given its simplicity and fast sample preparation, it may be considered for wide clinical use.…”

Section: Discussionmentioning

confidence: 99%

“…14,15,18,21 For example, Koal et al 15 described an easy method with protein precipitation, IS, and good performance of RSD % but with a dryness step for samples and with a chromatographic run on a liquid chromatography-mass spectrometry system, which is a very expensive instrument.…”

Section: Discussionmentioning

confidence: 99%

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A Simple and Fast Method for Quantification of Ertapenem using Meropenem as Internal Standard in Human Plasma in a Clinical Setting

D’Avolio

Baietto

Rosa

et al. 2008

Therapeutic Drug Monitoring

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A high-performance liquid chromatography method for the determination of ertapenem in human plasma using ultraviolet detection (300 nm) was developed and validated. The method involved a simple organic protein precipitation that guarantees rapid sample preparation. By using meropenem as internal standard, it also guarantees improved precision (relative standard deviation <3.70) and accuracy (deviation from true value <6.58%). The method was linear from 0.59 to 150 microg/mL and reproducible. In conclusion, this method allows the measurement of ertapenem in human plasma and may be used for both clinical routine applications and pharmacokinetic studies.

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Section: Discussionsupporting

confidence: 74%

Section: Discussionmentioning

confidence: 99%

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A Simple and Fast Method for Quantification of Ertapenem using Meropenem as Internal Standard in Human Plasma in a Clinical Setting

D’Avolio

Baietto

Rosa

et al. 2008

Therapeutic Drug Monitoring

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“…Choice of sample preparation buffer (0.1 m m + 1% NaF) was made based on an abbreviated stability investigation that compared MES alone (0.1 m m ) with MES + 1% NaF for preserving ertapenem in the plasma matrix. Published work indicates the fragility of this drug in an aqueous matrix, and other investigators have settled on the use of MES to overcome this (Mundkowski et al ., ). We investigated two concentrations (100 and 10 µg/mL, n = 5 each) of ertapenem in plasma samples stored under refrigerated conditions (4°C) and from freeze–thaw cycles.…”

Section: Methodsmentioning

confidence: 97%

Quantification and validation of HPLC‐UV and LC‐MS assays for therapeutic drug monitoring of ertapenem in human plasma

Pickering

Brown

2012

Biomedical Chromatography

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Rapid and simple HPLC-UV and LC-MS methods were developed and validated for the quantification of ertapenem (Invanz™) in human plasma. Ertapenem is a unique drug in that current dosing recommendations call for a 1 g dose for normal renal function patients, despite body weight. These assays, which involve a protein precipitation followed by liquid-liquid extraction, allow for fast therapeutic drug monitoring of ertapenem in patients, which is especially useful in special populations. Both methods were sufficient to baseline resolve meropenem (internal standard) and ertapenem, and were validated over 3 days using a six-point calibration curve (0.5-50 µg/mL). Validation was collected using four different points on the calibrations curve yielding acceptable precision (<15% inter-day and intra-day; <20% for lower limit of quantitation, LLOQ) as well as accuracy (<15% inter-day and intra-day; <20% for LLOQ). The lower limit of detection (LOD) was determined to be 0.1 and 0.05 µg/mL for the HPLC-UV and LC-MS methods, respectively. The developed HPLC-UV and LC-MS methods for ertapenem quantification are fast, accurate and reproducible over the calibration range and can be used to determine ertapenem plasma concentrations for monitoring clinical efficacy.

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“…8 Several methods of liquid chromatography coupled to either UV absorbance or mass spectrometry detection have been developed for the quantification of ertapenem in human plasma. [9][10][11][12][13] A LC-MS method was developed for the quantification of ERP in human plasma by detecting the deprotonated molecular ion of ERP under negative ionization mode with lower limit of quantification of 0.5 or 1 µg/ml and analytical run time of more than 5 min. 14 Chromatography.…”

Section: 2mentioning

confidence: 99%

Development of Stability Indicating RP-HPLC Method for Ertapenem in Bulk Drug and Pharmaceutical Dosage Form

Jain

Jain²,

Jain

et al. 2017

Dhaka Univ. J. Pharm. Sci

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ABSTRACT:A simple, inexpensive, rapid and novel stability indicating isocratic HPLC method has been developed and validated for quantitative analysis of ertapenem sodium in the bulk drug and in pharmaceutical dosage form. An isocratic separation of ertapenem sodium was achieved on Hypersil BDS C 18 column (4.6 x 250 mm, 5 µ particle size) as the stationary phase with a flow rate of 1.2 ml/min and using a UV detector to monitor the eluate at 298 nm. The mobile phase consisted of acetonitrile : water (60:40v/v) and pH adjusted 2.9 by othophosphoric acid enabled separation of the drug from its degradation products. The method was validated for linearity, accuracy (recovery), precision, specificity and robustness. The linearity of the method was satisfactory over the range 2-10 µg/ml (correlation coefficient 0.999). Recovery of ertapenem sodium from the pharmaceutical dosage form ranged from 99.97 to 103.7%. Ertapenem sodium was subjected to stress conditions [hydrolysis (acid, base), oxidation, photolysis and thermal degradation] and the samples were analyzed by this method. The forceddegradation study with ertapenem sodium showed that it was degraded under basic condition. The drug was stable under the other stress conditions investigated. Ertapenem sodium was found to be less stable in solution state, whereas it was comparatively much stable in solid state. The degradation products were well resolved from main peak. The forced degradation study prove the stability indicating power of the method and therefore, the validated method may be useful for routine analysis of ertapenem sodium as bulk drug, in respective dosage forms, for dissolution studies and as stability indicating assay method in pharmaceutical laboratories and industries.

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A new simple HPLC assay for the quantification of ertapenem in human plasma, lung tissue, and broncho-alveolar lavage fluid

Cited by 18 publications

References 12 publications

A Simple and Fast Method for Quantification of Ertapenem using Meropenem as Internal Standard in Human Plasma in a Clinical Setting

A Simple and Fast Method for Quantification of Ertapenem using Meropenem as Internal Standard in Human Plasma in a Clinical Setting

Quantification and validation of HPLC‐UV and LC‐MS assays for therapeutic drug monitoring of ertapenem in human plasma

Development of Stability Indicating RP-HPLC Method for Ertapenem in Bulk Drug and Pharmaceutical Dosage Form

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