Development and validation of a simple and sensitive LC-MS/MS method for the quantification of cefazolin in human plasma and its application to a clinical pharmacokinetic study

Reeder, Joshua A.; Abdallah, Inas A.; Bach, Thanh; O'Sullivan, Cormac T; Xu, Yan; Nalbant, Demet; An, Guohua

doi:10.1016/j.jpba.2021.114521

Cited by 10 publications

(2 citation statements)

References 19 publications

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“…An aliquot of 500 μL spiked human plasma sample was transferred to an Eppendorf micro tube (2 ml), and vortex-mixed with 50 μL IS (26.02 ng.ml -1 ) for 30 s. 1 mL of cold acetonitrile was added to the sample and vortexed for 1 min then centrifuged (5 min at 13000 rpm, 2-8 °C). Finally,180 μL was injected into the LC-MS/MS unit (Reeder et al 2022).…”

Section: Sample Preparationsmentioning

confidence: 99%

Simple and rapid LC-MS/MS method for determination of Piribedil in human plasma

Alshishani

Hasan²,

Ghanayem³

et al. 2022

PHAR

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A sensitive, simple, and fast LC-MS/MS method of analysis was developed and validated for the determination of piribedil in human plasma. Piribedil was extracted by protein precipitation using acetonitrile and separated on C18 Phenomenex Gemini column (150 × 4.6mm, 5 µm) using isocratic elution of 75% of ammonium acetate buffer (10 mM) and 25% acetonitrile at a flow rate of 1 ml.min-1 over 5 min run time. Piribedil and d8-Piribedil, as internal standard, were detected and quantified in positive ion mode via MRM at m/z 299/135 and 307/135 for piribedil and d8–piribedil, respectively. The suggested method for piribedil was validated according to FDA and EMA guidelines. The standard calibration curve was linear over the concentration range of 3.4–5952 pg.ml-1. The intra-day precision was 2.45–9.94% and accuracy 92.78–99.97%. The inter-day precision was 2.14–5.47% and accuracy 95.73–101.99%. The recovery of analyte and IS was 96.94% and 111.18%, respectively. piribedil in plasma was stable at benchtop (short term) for 24 h, in autosampler tray for 48 h, in instrumentation room for 24 h (post-preparative), after 5 freeze-thaw cycles (–70 °C), and 11 days in the freezer (–70 °C). The validated method was successfully applied to a bioequivalence study of piribedil formulations involving 15 healthy Jordanian volunteers.

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Section: Sample Preparationsmentioning

confidence: 99%

Simple and rapid LC-MS/MS method for determination of Piribedil in human plasma

Alshishani

Hasan²,

Ghanayem³

et al. 2022

PHAR

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“…A liquid chromatography system hyphenated with tandem mass spectrometry (LC-MS/MS) system is widely used for the quantification analyses of chemical substances and biological components in various real samples. [1][2][3][4][5][6] In addition, by utilizing a multiple reaction monitoring (MRM) scan mode, an LC-MS/MS method is considered the gold standard for quantification analyses of known compounds. [7][8][9] To obtain precise quantified results from MRM chromatograms, it is important that repeatability in an LC-MS/MS system is suitably assessed.…”

Section: Introductionmentioning

confidence: 99%

Effects of digital processing on repeatability assessment of a multiple reaction monitoring liquid chromatography–tandem mass spectrometry system by ISO 11843‐7

Machida

Kotani

Hayashi³

et al. 2022

J Mass Spectrom

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ISO 11843 part 7 (ISO 11843-7) can provide a standard deviation (SD) of area measurements of a target peak through the stochastic behaviors of instrumental noises. The purpose of this study is to demonstrate that ISO 11843-7 can be applied to assess repeatability in an isocratic liquid chromatography-tandem mass spectrometry (LC-MS/MS) system without repetitive measurements. The relative standard deviation (RSD) of the peak area of ergosterol picolinyl ester, which was used as an example, on a multiple reaction monitoring (MRM) chromatogram was determined by ISO 11843-7. The RSD by ISO 11843-7 (N = 1) was within a 95% confidence band of the RSD by repetitive measurements (N = 6). Moreover, the effects of digital smoothing, such as moving average, were also examined on the repeatability assessment in LC-MS/MS by ISO 11843-7. From the results of the comparisons of the RSDs obtained by ISO 11843-7 and the repetitive measurements, it was shown that suitable RSDs of the peak area were obtained from the smoothed MRM chromatograms by the moving average for narrow data point windows (e.g., one-sixth of the peak width). In conclusion, the utility of repeatability assessment based on ISO 11843-7 has been expanded for the validation of an LC-MS/MS system.

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Untargeted Profiling of Shenfu Qiangxin Pills Based on High‐Resolution Mass Spectrometry and Absolute Quantitation of Multiple Components Using Parallel Reaction Monitoring

Gao,

Liang,

Zhang

et al. 2024

J of Separation Science

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Shenfu Qiangxin (SFQX) pills are proprietary traditional Chinese medicine used for the treatment of chronic heart failure with significant clinical effects. However, the systematic identification and quantification of complexed components in SFQX have not been reported yet. In this work, a reliable and comprehensive method for a rapid identification of chemical components was developed by data dependent acquisition using ultra performance liquid chromatography coupled with high‐resolution mass spectrometry (UHPLC‐Q Exactive‐Orbitrap‐MS). A total of 104 compounds mainly including flavonoids, saponins, alkaloids, anthraquinones, coumarins, and phenolic acids were identified through database searching. The identified compounds were further ascribed to herb species in SFQX pills, such as Ginseng Radis et Rhizoma, Aconiti Lateralis Radix Praeparata (processed), Mori Cortex, Lepidii Semen, Rhei Radix et Rhizoma, and Polyporus. Thirty‐two representative compounds were elaborated with cleavage pathways and characteristic fragments in MS/MS spectrum of commercially available standards. A quantification method based on parallel reaction monitoring technique was established, and absolute quantification of 28 components in SFQX pills was then carried out. This work constitutes a basis and methodological reference for the quality control, consistency evaluation, and standardization of similar proprietary Chinese medicines.

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Development and validation of a simple and sensitive LC-MS/MS method for the quantification of cefazolin in human plasma and its application to a clinical pharmacokinetic study

Cited by 10 publications

References 19 publications

Simple and rapid LC-MS/MS method for determination of Piribedil in human plasma

Simple and rapid LC-MS/MS method for determination of Piribedil in human plasma

Effects of digital processing on repeatability assessment of a multiple reaction monitoring liquid chromatography–tandem mass spectrometry system by ISO 11843‐7

Untargeted Profiling of Shenfu Qiangxin Pills Based on High‐Resolution Mass Spectrometry and Absolute Quantitation of Multiple Components Using Parallel Reaction Monitoring

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Development and validation of a simple and sensitive LC-MS/MS method for the quantification of cefazolin in human plasma and its application to a clinical pharmacokinetic study

Cited by 10 publications

References 19 publications

﻿Simple and rapid LC-MS/MS method for determination of Piribedil in human plasma

﻿Simple and rapid LC-MS/MS method for determination of Piribedil in human plasma

Effects of digital processing on repeatability assessment of a multiple reaction monitoring liquid chromatography–tandem mass spectrometry system by ISO 11843‐7

Untargeted Profiling of Shenfu Qiangxin Pills Based on High‐Resolution Mass Spectrometry and Absolute Quantitation of Multiple Components Using Parallel Reaction Monitoring

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Simple and rapid LC-MS/MS method for determination of Piribedil in human plasma

Simple and rapid LC-MS/MS method for determination of Piribedil in human plasma