Simultaneous determination of cefdinir and cefixime in human plasma by RP-HPLC/UV detection method: Method development, optimization, validation, and its application to a pharmacokinetic study

Khan, Abbas; Iqbal, Zafar; Khan, Muhammad Imran; Javed, K.H.; Khan, Abad; Ahmad, Lateef; Shah, Yatrik M.; Nasir, Fazli

doi:10.1016/j.jchromb.2011.06.040

Cited by 43 publications

(23 citation statements)

References 18 publications

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“…As a result, many organisms resistant to penicillin's and some cephalosporin are susceptible to Cefdinir [9]. Entire survey of the literature of cefdinir exposed several methods for determination in pharmaceutical formulations and biological matrices like spectro-photometry [10], polarographic technique [11], HPLC [12] and LC/MS/MS methods [13]. However, maximum of these analytical methods do not appear to have general utility especially at the industrial level where simple, cost-effective and specific methods are needed [14].…”

Section: Methodsmentioning

confidence: 99%

Development and Validation of New Rp-Uplc Method for the Determination of Cefdinir in Bulk and Dosage Form

Ponnekanti

Sundararajan

2018

Int J Pharm Pharm Sci

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Objective: The objective of the study was to develop and validate a new rapid and sensitive reverse phase ultra-performance liquid chromatographic (RP-UPLC) method for determination of cefdinir in bulk drug and dosage form.Methods: Separation was achieved with an Acquity SB C18 (100 × 2 mm) 1.8μm column with an isocratic mobile phase containing a mixture of orthophosphoric acid and acetonitrile (60:40 v/v) and pH adjusted to 2.8. The flow rate of the mobile phase was 0.3 ml/min with a column temperature of 30 °C and detection wavelength at 285 nm. Results:The method was validated with respect to linearity, accuracy, precision, detection limits, robustness and specificity. The precision of the results, stated as the relative standard deviation was below 1.5%. The calibration curve was linear over a concentration range from 25 to 150μg/ml with a correlation coefficient of 0.9993. The accuracy of the method demonstrated at three levels in the range of 50%, 100% and 150% of the specification limit. The recovery of cefdinir was found to be in the range of 98 to 102%, whereas the detection limits were found to be 0.17 and 0.51µg/ml. Forced degradation study was carried out under acidic, alkaline, oxidative, photolytic and thermal conditions to prove the stabilityindicating ability of the developed UPLC method. Conclusion:The developed method was validated with respect to linearity, accuracy, precision limit of detection and quantification, robustness and specificity. The method was applied successfully for the determination of cefdinir in tablets.

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Section: Methodsmentioning

confidence: 99%

Development and Validation of New Rp-Uplc Method for the Determination of Cefdinir in Bulk and Dosage Form

Ponnekanti

Sundararajan

2018

Int J Pharm Pharm Sci

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“…Therefore, with the current limitations the use of immunoassays for antibiotics' TDM is not considered as a priority for further development and efforts have been directed to explore other alternatives such as the use of chromatographic techniques. Consequently, liquid-chromatography (LC) coupled to UV [28,[56][57][58][59], chemiluminescence (CL) [60], electrochemical (EC) [61], and mass spectrometry (MS) [62,63], have been widely/successfully used for the detection of β-lactams. Although as compared to mass spectrometry less sophisticated analysis is performed with the use of the other conventional detectors, the speed and sensitivity of the former one surpass those offered by the latter ones (UV, CL, EC).…”

Section: Overview Of Published Analytical Methods Optimized For Theramentioning

confidence: 99%

“…Sample cleanup procedures for β-lactam antibiotics include solid phase extraction [58,60,62,67,72], liquidliquid extraction [59] and protein precipitation using acids [56,61] and organic solvents i.e. : methanol or acetonitrile [64,72,74].…”

Section: Sample Treatmentmentioning

confidence: 99%

“…It seems, on the other hand, that the concentration of acid that increases the degradation is antibiotic dependent. For instance, while 6% and 30% TCA have been effectively used, respectively, for the extraction of cefdinir/cefexime [56] and ceftazidime [61], 10% TCA significantly affected the stability of other β-lactams particularly meropenem [74]. The stability of β-lactams is also significantly affected in the presence of zinc sulfate and, therefore, its use as a precipitant should be avoided [76].…”

Section: Sample Treatmentmentioning

confidence: 99%

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The use of liquid chromatography-tandem mass spectrometry for therapeutic drug monitoring of antibiotics in cancer patients

El‐Najjar

Gessner

2017

Clinical Chemistry and Laboratory Medicine (CCLM)

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Cancer remains a leading cause of mortality and morbidity worldwide. In addition to organ failure, the most frequent reasons for admission of cancer patients to intensive care units (ICU) are: infections and sepsis. As critically ill, the complexity of the health situation of cancer patients renders the standard antimicrobial regimen more complex and even inadequate which results in increased mortality rates. This is due to pathophysiological changes in the volume of distribution, increased clearance, as well as to organ dysfunction. While in the former cases a decrease in drug efficacy is observed, the hallmark of the latter one is overdosing leading to increased toxicity at the expense of efficacy. Furthermore, an additional risk factor is the potential drug-drug interaction between antibiotics and antineoplastic agents. Therefore, therapeutic drug monitoring (TDM) is a necessity to improve the clinical outcome of antimicrobial therapy in cancer patients. To be applied in routine analysis the method used for TDM should be cheap, fast and highly accurate/sensitive. Furthermore, as ICU patients are treated with a cocktail of antibiotics the method has to cover the simultaneous analysis of antibiotics used as a first/second line of treatment. The aim of the current review is to briefly survey the pitfalls in the current antimicrobial therapy and the central role of TDM in dose adjustment and drug-drug interaction's evaluation. A major section is dedicated to summarize the currently published analytical methods and to shed light on the difficulties and potential problems that can be encountered during method development.

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“…In addition, Cazorla Reyes et al also developed a liquid chromatography tandem mass spectrometry method for the analysis of 21 antibiotics including cephalosporins and various other antibiotics in plasma, urine, cerebrospinal fluid and bronchial aspiration matrix (Cazorla-Reyes, Romero-González, Frenich, Rodríguez Maresca, & Martínez Vidal, 2014). Although several HPLC methods have been developed, some are limited to quantification of one or two drugs (Bhinge, Malipatil, & Sonawane, 2014;Danafar, 2015;El-Gindy et al, 2000;Khan et al, 2011), while others have been developed for the detection of 5-12 cephalosporins (Denooz & Charlier, 2008;Legrand, Vodovar, Tournier, Khoudour, & Hulin, 2016;Verdier et al, 2011;Wolff et al, 2013). In addition, many methods using liquid chromatography coupled to tandem mass spectrometric detection (LC/MS-MS) were set up to measure simultaneously from five to 11 cephalosporins (Carlier, Stove, De Waele, & Verstraete, 2015;Colin, DE Bock, T'jollyn, Boussery, & Van Bocxlaer, 2013).…”

mentioning

confidence: 99%

Investigation of early antibiotic use in pediatric patients with acute respiratory infections by high‐performance liquid chromatography

Toi

Doan

Minh

et al. 2019

Biomedical Chromatography

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In this study, we developed and validated two reliable high‐performance liquid chromatography (HPLC) methods for the qualitative detection of six oral β‐lactams, which are commonly used in pediatric patients with acute respiratory infections (ARIs). Two distinct reverse‐phase chromatographic separations of six β‐lactams were obtained. Four β‐lactams (cefadroxil, cephalexin, cefaclor and cefixime) in urine were separated using a gradient program with a mobile phase consisting of K2HPO4 buffer (20 mm, pH 2.8) and acetonitrile on a LichroCART 250 × 4.6 mm, Purospher STAR C18 end‐capped (5 μm) column. Two remained β‐lactams (amoxicillin and cefuroxime) were analyzed using a gradient elution with the mobile phase containing K2HPO4 buffer (20 mm, pH 3.0) and acetonitrile on a LichroCart® Purospher Star C8 end‐capped column (5 μm, 125 × 4.6 mm). Good linearity within the range of 0.3–30 μg/ml for cefadroxil, cephalexin, cefaclor and cefixime, and 0.2–20 μg/ml for amoxicillin and cefuroxime, was attained. The precisions were <14%. The accuracies ranged from 85.87 to 102.8%. The two validated methods were then applied to determine these six antibiotics in 553 urine samples of pediatric patients with ARIs. As a result, 32.2% were positive with one or more of six tested β‐lactams. Cefixime was the most commonly detected agent, accounting for 9.8% of enrolled patients.

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Simultaneous determination of cefdinir and cefixime in human plasma by RP-HPLC/UV detection method: Method development, optimization, validation, and its application to a pharmacokinetic study

Cited by 43 publications

References 18 publications

Development and Validation of New Rp-Uplc Method for the Determination of Cefdinir in Bulk and Dosage Form

Development and Validation of New Rp-Uplc Method for the Determination of Cefdinir in Bulk and Dosage Form

The use of liquid chromatography-tandem mass spectrometry for therapeutic drug monitoring of antibiotics in cancer patients

Investigation of early antibiotic use in pediatric patients with acute respiratory infections by high‐performance liquid chromatography

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