Development and validation of a novel UPLC-MS/MS method for quantification of delafloxacin in plasma and aqueous humour for pharmacokinetic analyses

Iqbal, Muzaffar; Ezzeldin, Essam; Herqash, Rashed N.; Anwer, Md. Khalid; Azam, Faizul

doi:10.1016/j.jchromb.2019.121961

Cited by 15 publications

(29 citation statements)

References 20 publications

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“…Our recently published UPLC-MS/MS method [36] was used for the quantitative analysis of DFL in rat plasma samples. All plasma samples were kept frozen at −80 • before analysis.…”

Section: Bio-analytical Methodsmentioning

confidence: 99%

Development of Lipomer Nanoparticles for the Enhancement of Drug Release, Anti-Microbial Activity and Bioavailability of Delafloxacin

et al. 2020

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Delafloxacin (DFL) is a novel potent and broad-spectrum fluoroquinolone group of antibiotics effective against both Gram-positive and negative aerobic and anaerobic bacteria. In this study, DFL-loaded stearic acid (lipid) chitosan (polymer) hybrid nanoparticles (L-P-NPs) have been developed by single-emulsion-solvent evaporation technique. The mean particle size and polydispersity index (PDI) of optimized DFL-loaded L-P-NPs (F1-F3) were measured in the range of 299–368 nm and 0.215–0.269, respectively. The drug encapsulation efficiency (EE%) and loading capacity (LC%) of DFL-loaded L-P-NPs (F1-F3) were measured in the range of 64.9–80.4% and 1.7–3.8%, respectively. A sustained release of DFL was observed from optimized DFL-loaded L-P-NPs (F3). Minimum inhibitory concentration (MIC) values of the DFL-loaded L-P-NPs (F3) appeared typically to be four-fold lower than those of delafloxacin in the case of Gram-positive strains and was 2-4-fold more potent than those of delafloxacin against Gram-negative strains. The pharmacokinetic study in rats confirmed that the bioavailability (both rate and extent of absorption) of DFL-loaded L-P-NPs was significantly higher (2.3-fold) than the delafloxacin normal suspension. These results concluded that the newly optimized DFL-loaded L-P-NPs were more potent against both Gram-positive and negative strains of bacteria and highly bioavailable in comparison to delafloxacin normal suspension.

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“…Our recently published UPLC-MS/MS method [36] was used for the quantitative analysis of DFL in rat plasma samples. All plasma samples were kept frozen at −80 • before analysis.…”

Section: Bio-analytical Methodsmentioning

confidence: 99%

Development of Lipomer Nanoparticles for the Enhancement of Drug Release, Anti-Microbial Activity and Bioavailability of Delafloxacin

et al. 2020

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“…Six different batches of blank human plasma were spiked with LLOQ concentration of DLX (16 ng/band) and IS (100 ng/band). DLX and IS were separated by a protein precipitation method and quantification was carried out by the proposed HPTLC technique [10,21].…”

Section: Selectivity and Specificitymentioning

confidence: 99%

“…DLX is rapidly absorbed after oral administration as its peak plasma concentration is reached within 1-2.5 h [8,9]. Compared with other fluoroquinolone antibiotics, the absolute bioavailability of DLX has been reported as low (58.8%) which could be due to its weak solubility in water [10]. For the treatment of ABSSSIs and CARTIs, the frequent oral dosing of DLX is required [7,11].…”

Section: Introductionmentioning

confidence: 99%

“…However, frequent oral administrations are often discouraged due to patient compliance reason which may lead to resistance for fluoroquinolones in the treatment of ABSSSIs and CARTIs [12]. A thorough literature survey revealed a single ultra-performance liquid chromatography-mass spectrometry/mass spectrometry (UPLC-MS/MS) technique for the determination of DLX in rat plasma and rabbit aqueous humor [10]. Some researchers reported the assay for the assessment of pharmacokinetic profile of DLX in healthy human volunteers and some diseased patients [11,13,14].…”

Section: Introductionmentioning

confidence: 99%

“…To the best of the authors' knowledge, not a single high-performance thin-layer chromatography (HPTLC) method has been reported for the estimation of DLX in pharmaceutical dosage forms and/or biological samples such as rat or human plasma. Although, UPLC-MS/MS method was developed and validated well for the determination of DLX in biological samples, but the cost and maintenance of UPLC-MS/MS apparatus is expensive [10,15]. In addition, highly-skilled technical personnel are required to operate such apparatus and hence not commonly available in most of the laboratories.…”

Section: Introductionmentioning

confidence: 99%

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Simple and Accurate HPTLC-Densitometric Method for Quantification of Delafloxacin (A Novel Fluoroquinolone Antibiotic) in Plasma Samples: Application to Pharmacokinetic Study in Rats

et al. 2020

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Delafloxacin (DLX) is a recently-approved fluoroquinolone antibiotic, which is recommended for the treatment of “acute bacterial skin and skin structure infections”. A thorough literature survey revealed only a single published method for the estimation of DLX using UPLC-MS/MS technique in biological samples. There is no high-performance thin-layer chromatography (HPTLC) method has been reported for the estimation of DLX in dosage forms and/or biological samples. Therefore, a selective, sensitive, rapid and validated HPTLC-densitometry technique has been used for the estimation of DLX in human plasma for the first time. HPTLC quantification of DLX and internal standard (IS; gatifloxacin) was carried out on glass coated silica gel 60 F254 HPTLC plates using the ternary mixture of ethyl acetate:methanol:ammonia solution 5:4:2 (%, v/v/v) as the mobile phase. Densitometric detection was done at 344 nm. The Rf values were recorded as 0.43 and 0.27 for the DLX and the IS, respectively. The linearity range of DLX was obtained as 16–400 ng/band. A simple protein precipitation method was used for the extraction of analyte from plasma using methanol. The proposed HPTLC technique was validated for “linearity, accuracy, precision, and robustness”. The proposed HPTLC technique was successfully utilized for the assessment of pharmacokinetic profile of DLX in rats after oral administration. After oral administration, the peak plasma concentration of DLX was obtained as 194.19 ng/ml in 1 h. The proposed HPTLC method could be applied in study of pharmacokinetic profile and therapeutic drug monitoring of DLX in clinical practice.

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A UPLC–MS/MS method for simultaneous determination of nine antiepileptic drugs in human plasma and its application in TDM

Liu

2021

Biomedical Chromatography

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With the purpose of carrying out therapeutic drug monitoring (TDM) of nine antiepileptic drugs simultaneously in the clinic, a UPLC-MS/MS assay method was developed and validated. Separation of antiepileptic drugs and internal standard (naproxen and diazepam) was performed on an Agilent Eclipse XDB-C 18 column (50.0 × 2.1 mm, 1.7 μm) using water and acetonitrile as mobile phase for gradient elution. Polarity switch ionization mode (positive-negative-positive) was performed in a total run time of 3.0 min. The method validation was conducted based on bioanalytical method validation guidance, including specificity, calibration curve, precision, accuracy, recovery, matrix effect, stability and dilution integrity, and all of the results satisfied the requirements. Consequently, the proposed method was applied to the TDM of nine antiepileptic drugs and was proved to be sensitive, reliable and specific to determine antiepileptic drugs in human plasma simultaneously.Meanwhile, the TDM results showed that the plasma drug concentration of many patients was not within the effective therapeutic range, especially those taking topiramate, oxcarbazepine and levetiracetam, which was of great guiding significance to rational drug use and timely adjustment of the treatment plan. Therefore, individualized therapy based on advanced analytical methods and TDM theory is of great practical significance.

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Development and validation of a novel UPLC-MS/MS method for quantification of delafloxacin in plasma and aqueous humour for pharmacokinetic analyses

Cited by 15 publications

References 20 publications

Development of Lipomer Nanoparticles for the Enhancement of Drug Release, Anti-Microbial Activity and Bioavailability of Delafloxacin

Development of Lipomer Nanoparticles for the Enhancement of Drug Release, Anti-Microbial Activity and Bioavailability of Delafloxacin

Simple and Accurate HPTLC-Densitometric Method for Quantification of Delafloxacin (A Novel Fluoroquinolone Antibiotic) in Plasma Samples: Application to Pharmacokinetic Study in Rats

A UPLC–MS/MS method for simultaneous determination of nine antiepileptic drugs in human plasma and its application in TDM

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