Development and validation of a quantitative HPLC/MS/MS method for the determination of piperacillin in blood plasma
Authors
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Vladimir I. Petrov
Volgograd State Medical University of the Ministry of Health of the Russian Federation; Center for Innovative Medicines with Pilot Production of Volgograd State Medical University
https://orcid.org/0000-0002-0258-4092
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Ivan S. Anikeev
Volgograd 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 Federation
https://orcid.org/0000-0002-9384-4338
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Tatyana E. Zayachnikova
Institute of Continuing Medical and Pharmaceutical Education of Volgograd State Medical University
https://orcid.org/0000-0001-6758-4686
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Andrey V. Strygin
Volgograd State Medical University; Center for Innovative Medicines with Pilot Production of Volgograd State Medical University; State budgetary institution Volgograd Medical Research Center
https://orcid.org/0000-0002-6997-1601
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Anna M. Dotsenko
Volgograd State Medical University; Center for Innovative Medicines with Pilot Production of Volgograd State Medical University; State budgetary institution Volgograd Medical Research Center
https://orcid.org/0000-0003-3324-3351
DOI:
https://doi.org/10.18413/rrpharmacology.9.10027Abstract
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.
Graphical Abstarct
Keywords:
HPLC/MS, validation, quantitation, piperacillin, bioanalyticsReferences
Anikeev IS, Osadchenko NA, Basargina PS, Zhukovskaya YuA, Mileeva YuS (2018) Development of a highly sensitive chromato-mass spectrometric method for the determination of vancomycin and piperacillin in blood plasma. In: Actual Problems of Experimental and Clinical Medicine Materials of the 76th international scientific and practical conference of young scientists and students, VolgGMU, Volgograd p. 521–522. [in Russian]
Council of the Eurasian Economic Commission (2016) On approval of the rules for conducting bioequivalence studies of medicinal products within the framework of the Eurasian Economic Union, Astana, 161 pp. [in Russian]
Barco S, Bandettini R, Maffia A, Tripodi G, Castagnola E, Cangemi G (2015) Quantification of piperacillin, tazobactam, meropenem, ceftazidime, and linezolid in human plasma by liquid chromatography/tandem mass spectrometry. Journal of Chemotherapy 27(6): 343–347. https://doi.org/10.1179/1973947814Y.0000000209 [PubMed]
Berm EJ, Odigie B, Bijlsma MJ, Wilffert B, Touw DJ, Maring JG (2016) A clinical validation study for application of DBS in therapeutic drug monitoring of antidepressants. Bioanalysis 8(5): 413–424. https://doi.org/10.4155/bio.15.255[PubMed]
Capiau S, Veenhof H, Koster RA, Bergqvist Y, Boettcher M, Halmingh O, Keevil BG, Koch BCP, Linden R, Pistos C, Stolk LM, Touw DJ, Stove CP, Alffenaar JC (2019) Official International association for therapeutic drug monitoring and clinical toxicology guideline: Development and validation of dried blood spot-based methods for therapeutic drug monitoring. Therapeutic Drug Monitoring 41(4): 409–430. https://doi.org/10.1097/FTD.0000000000000643 [PubMed]
Cohen-Wolkowiez M, Watt KM, Zhou C, Bloom BT, Poindexter B, Castro L, Gao J, Capparelli EV, Benjamin DK Jr, Smith PB. (2014) Developmental pharmacokinetics of piperacillin and tazobactam using plasma and dried blood spots from infants. Antimicrobial Agents and Chemotherapy 58(5): 2856–2865. https://doi.org/10.1128/AAC.02139-13[PubMed] [PMC]
D'Cunha R. et al. Quantification of cefepime, meropenem, piperacillin and tazobactam in human plasma using a sensitive and robust LC-MS/MS method-Part I. Assay development and validation //Antimicrobial Agents and Chemotherapy. – 2018. – С. AAC. 00859-18. https://doi.org/10.1128/AAC.00859-18 [PubMed] [PMC]
Fan Y, Peng X, Yu J, Liang X, Chen Y, Liu X, Guo B, Zhang J (2019) An ultra-performance liquid chromatography-tandem mass spectrometry method to quantify vancomycin in human serum by minimizing the degradation product and matrix interference. Bioanalysis 11(10): 941–955. https://doi.org/10.4155/bio-2018-0310 [PubMed]
Hagel S, Fiedler S, Hohn A, Brinkmann A, Frey OR, Hoyer H, Schlattmann P, Kiehntopf M, Roberts JA, Pletz MW; TARGET Study Group (2019) Therapeutic drug monitoring-based dose optimization of piperacillin/tazobactam to improve outcome in patients with sepsis (TARGET): a prospective, multi-centre, randomised controlled trial. Trials 20(1): 330. https://doi.org/10.1186/s13063-019-3437-x [PubMed] [PMC]
Jager NG, Rosing H, Schellens JH, Beijnen JH (2014) Procedures and practices for the validation of bioanalytical methods using dried blood spots: a review. Bioanalysis 6(18): 2481–2514. https://doi.org/10.4155/bio.14.185 [PubMed]
Keçeli SA, Willke A, Tamer GS, Boral OB, Sonmez N, Cağatay P (2014) Interaction between caspofungin or voriconazole and cefoperazone-sulbactam or piperacillin-tazobactam by in vitro and in vivo methods. APMIS 122(5): 412–417. https://doi.org/10.1111/apm.12159 [PubMed]
Li Z, Li Q, Wang Y, Cao D, Chen C (2012) Determination of free and total piperacillin–tazobactam in plasma by HPLC–MS–MS: An adapted method for neonates. Chromatographia 75: 533–539 https://doi.org/10.1007/s10337-012-2214-8
Li Q, Cao D, Huang Y, Xu H, Yu C, Li Z (2013) Development and validation of a sensitive LC-MS/MS method for determination of tacrolimus on dried blood spots. Biomedical Chromatography 27(3): 327–334. https://doi.org/10.1002/bmc.2795
Mu A (2019) The application of dried blood spots in toxicokinetic and pharmacokinetic studies. Journal of Chemical Information and Modeling 9: 1689–1699.
Schmitt V, Szeitz A, Klassen T, Häfeli U (2017) An ultra-high performance liquid chromatography-tandem mass spectrometry method for the quantification of vancomycin requiring only 2 µL of rabbit serum. American Journal of Analytical Chemistry 8(9): 553–563. https://doi.org/10.4236/ajac.2017.89040
Timmerman P, White S, Globig S, Lüdtke S, Brunet L, Smeraglia J (2011) EBF recommendation on the validation of bioanalytical methods for dried blood spots. Bioanalysis 3(14): 1567–1575. https://doi.org/10.4155/bio.11.132 [PubMed]
Verhoven SM, Groszek JJ, Fissell WH, Seegmiller A, Colby J, Patel P, Verstraete A, Shotwell M (2018) Therapeutic drug monitoring of piperacillin and tazobactam by RP-HPLC of residual blood specimens. Clinica Chimica Acta 482: 60–65. https://doi.org/10.1016/j.cca.2018.03.021 [PubMed] [PMC]
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