Development and validation of a quantitative HPLC/MS/MS method for the determination of piperacillin in blood plasma

Introduction: Reduced mortality in patients with sepsis taking piperacillin is possible when they receive a long-term infusion, which improves the effect of antimicrobials. However, such piperacillin therapy requires therapeutic drug monitoring, the use of the latest analytical equipment and develop...

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Main Authors: Vladimir I. Petrov, Ivan S. Anikeev, Tatyana E. Zayachnikova, Andrey V. Strygin, Anna M. Dotsenko
Format: Article
Language:English
Published: Belgorod National Research University 2023-06-01
Series:Research Results in Pharmacology
Subjects:
Online Access:https://rrpharmacology.ru/index.php/journal/article/view/360/357
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author Vladimir I. Petrov
Ivan S. Anikeev
Tatyana E. Zayachnikova
Andrey V. Strygin
Anna M. Dotsenko
author_facet Vladimir I. Petrov
Ivan S. Anikeev
Tatyana E. Zayachnikova
Andrey V. Strygin
Anna M. Dotsenko
author_sort Vladimir I. Petrov
collection DOAJ
description Introduction: Reduced mortality in patients with sepsis taking piperacillin is possible when they receive a long-term infusion, which improves the effect of antimicrobials. However, such piperacillin therapy requires therapeutic drug monitoring, the use of the latest analytical equipment and developed methods for the quantitative determination of piperacillin. Materials and Methods: Dry samples of the appropriate certified piperacillin standards were used to prepare stock and standard solutions of piperacillin. Separation of the components was performed using an Agilent 1260 HPLC system with a binary pump and a temperature controlled autosampler. Analyses were detected using a Sciex QTRAP 5500 hybrid mass spectrometric system. Validation of the developed method was carried out in accordance with the rules for conducting bioequivalence studies of drugs within the framework of the Eurasian Economic Union; 2016, in Astana. Results and Discussion: Piperacillin ions-”precursors” corresponded to particles m/z 518.2. The most intense ions-”products” registered during the fragmentation of protonated molecules in the collision cell were particles m/z 143.1 and m/z 115.0. During the validation of the developed method, the main validation parameters were established: linearity, accuracy, accuracy, and sensitivity (lower limit of quantitation). Conclusion: The validated analytical range of the method was 0.5–100 µg/mL in plasma. The resulting analytical range makes it possible to apply the developed method for conducting the analytical part of studies of the pharmacokinetics of piperacillin.
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spelling doaj.art-41fe9f3ba77a4f1797955836227a5e102024-01-16T15:07:05ZengBelgorod National Research UniversityResearch Results in Pharmacology2658-381X2023-06-0192555910.18413/rrpharmacology.9.10027Development and validation of a quantitative HPLC/MS/MS method for the determination of piperacillin in blood plasmaVladimir I. Petrov0https://orcid.org/0000-0002-0258-4092Ivan S. Anikeev1https://orcid.org/0000-0002-9384-4338Tatyana E. Zayachnikova2https://orcid.org/0000-0001-6758-4686Andrey V. Strygin3https://orcid.org/0000-0002-6997-1601Anna M. Dotsenko4https://orcid.org/0000-0003-3324-3351Volgograd State Medical University of the Ministry of Health of the Russian Federation; Center for Innovative Medicines with Pilot Production of Volgograd State Medical UniversityVolgograd State Medical University of the Ministry of Health of the Russian Federation; Center for Innovative Medicines with Pilot Production of Volgograd State Medical University of the Ministry of Health of the Russian FederationInstitute of Continuing Medical and Pharmaceutical Education of Volgograd State Medical UniversityVolgograd State Medical University; Center for Innovative Medicines with Pilot Production of Volgograd State Medical University; State budgetary institution Volgograd Medical Research CenterVolgograd State Medical University; Center for Innovative Medicines with Pilot Production of Volgograd State Medical University; State budgetary institution Volgograd Medical Research CenterIntroduction: Reduced mortality in patients with sepsis taking piperacillin is possible when they receive a long-term infusion, which improves the effect of antimicrobials. However, such piperacillin therapy requires therapeutic drug monitoring, the use of the latest analytical equipment and developed methods for the quantitative determination of piperacillin. Materials and Methods: Dry samples of the appropriate certified piperacillin standards were used to prepare stock and standard solutions of piperacillin. Separation of the components was performed using an Agilent 1260 HPLC system with a binary pump and a temperature controlled autosampler. Analyses were detected using a Sciex QTRAP 5500 hybrid mass spectrometric system. Validation of the developed method was carried out in accordance with the rules for conducting bioequivalence studies of drugs within the framework of the Eurasian Economic Union; 2016, in Astana. Results and Discussion: Piperacillin ions-”precursors” corresponded to particles m/z 518.2. The most intense ions-”products” registered during the fragmentation of protonated molecules in the collision cell were particles m/z 143.1 and m/z 115.0. During the validation of the developed method, the main validation parameters were established: linearity, accuracy, accuracy, and sensitivity (lower limit of quantitation). Conclusion: The validated analytical range of the method was 0.5–100 µg/mL in plasma. The resulting analytical range makes it possible to apply the developed method for conducting the analytical part of studies of the pharmacokinetics of piperacillin.https://rrpharmacology.ru/index.php/journal/article/view/360/357hplc/msvalidationquantitationpiperacillinbioanalytics
spellingShingle Vladimir I. Petrov
Ivan S. Anikeev
Tatyana E. Zayachnikova
Andrey V. Strygin
Anna M. Dotsenko
Development and validation of a quantitative HPLC/MS/MS method for the determination of piperacillin in blood plasma
Research Results in Pharmacology
hplc/ms
validation
quantitation
piperacillin
bioanalytics
title Development and validation of a quantitative HPLC/MS/MS method for the determination of piperacillin in blood plasma
title_full Development and validation of a quantitative HPLC/MS/MS method for the determination of piperacillin in blood plasma
title_fullStr Development and validation of a quantitative HPLC/MS/MS method for the determination of piperacillin in blood plasma
title_full_unstemmed Development and validation of a quantitative HPLC/MS/MS method for the determination of piperacillin in blood plasma
title_short Development and validation of a quantitative HPLC/MS/MS method for the determination of piperacillin in blood plasma
title_sort development and validation of a quantitative hplc ms ms method for the determination of piperacillin in blood plasma
topic hplc/ms
validation
quantitation
piperacillin
bioanalytics
url https://rrpharmacology.ru/index.php/journal/article/view/360/357
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AT tatyanaezayachnikova developmentandvalidationofaquantitativehplcmsmsmethodforthedeterminationofpiperacillininbloodplasma
AT andreyvstrygin developmentandvalidationofaquantitativehplcmsmsmethodforthedeterminationofpiperacillininbloodplasma
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