Development and validation of an integrated LC-MS/MS assay for therapeutic drug monitoring of five PARP-inhibitors

Bruin, Michiel de; Vries, Niels de; Lucas, Linda M.; Rosing, Hilde; Huitema, Alwin D. R.; Beijnen, Jos H.

doi:10.1016/j.jchromb.2019.121925

Cited by 18 publications

(40 citation statements)

References 31 publications

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“…These methods could be useful if the analyst is interested in quantifying all the drugs included in the assay; otherwise, a single-analyte method might be more convenient and easier to transfer from one laboratory to another. Finally, the method proposed by Bruin et al 23 allows the use of a single assay to simultaneously quantify all the FDA-approved and EMA-approved PARPis, along with veliparib, which is yet to be approved by the regulatory agencies. Reportedly, this is the first published method to quantify talazoparib in human plasma.…”

Section: Bioanalytical Methods For Parp Inhibitor Quantificationmentioning

confidence: 99%

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Bioanalytical Methods for Poly(ADP-Ribose) Polymerase Inhibitor Quantification: A Review for Therapeutic Drug Monitoring

Orleni

Canil

Posocco

et al. 2023

Therapeutic Drug Monitoring

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Background: Therapeutic drug monitoring (TDM) of poly(ADP-ribose) polymerase inhibitors (PARPis) is an exploratory practice aimed at improving the quality of treatment through personalized therapy. Currently, there are 4 European Medicines Agency-approved and US Food and Drug Administration–approved PARPis available clinically whose quantification requires validated analytical methods: olaparib, niraparib, rucaparib, and talazoparib. The purpose of this literature review was to highlight the pharmacological features of PARPis that could support their TDM practice and provide a detailed discussion of the available liquid chromatography coupled with tandem mass spectrometry methods for their quantification. Methods: Using several Medical Subject Heading terms, the literature was searched using several research engines, including SciFinder, Web of Science, Google Scholar, and PubMed, to find articles published before August 2022. Results: Exposure-efficacy and exposure-safety profiles, drug–drug interactions, and hepatic/renal impairment of PARPis provide the potential rationale to monitor their concentrations through TDM. Several bioanalytical methods for their quantification have been reported and compared, and a great deal of heterogeneity has been found among methods, regarding both their analytical and regulatory aspects. Conclusions: In addition to reducing toxicity and increasing the efficacy of PARPis therapy, TDM could be beneficial to thoroughly investigate the exposure–response relationships of PARPis and to establish pharmacokinetic thresholds for clinical decisions. Based on the comparison of published bioanalytical methods, their transferability and validation both play a key role in method selection. For future use in clinical TDM, we anticipate that bioanalytical methods should address every analytical need more thoroughly and should be validated with standardized guidelines.

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Section: Bioanalytical Methods For Parp Inhibitor Quantificationmentioning

confidence: 99%

“…Reportedly, this is the first published method to quantify talazoparib in human plasma. 23 Table 2 summarizes the details of all bioanalytical methods.…”

Section: Bioanalytical Methods For Parp Inhibitor Quantificationmentioning

confidence: 99%

Bioanalytical Methods for Poly(ADP-Ribose) Polymerase Inhibitor Quantification: A Review for Therapeutic Drug Monitoring

Orleni

Canil

Posocco

et al. 2023

Therapeutic Drug Monitoring

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“…The complete information with data supplemented from the literature that there are only few methods like LC-MS/MS [2] [3] [4] [5] techniques which are very expensive but there was no simple method developed till date for the analysis of Rucaparib drug. Hence, it felt necessary to establish a new, easier, cost effective, precise, accurate and specific stability indicating analytical method which can be easily applicable for routine drug performance evaluations.…”

Section: Introductionmentioning

confidence: 99%

A Stability Indicating Reverse Phase-HPLC Method Development and Validation for the Estimation of Rucaparib in Bulk and Pharmaceutical Dosage Form

Suchitra¹,

Satyanarayana²

2021

AJAC

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“…Chemically, Niraparib is ((S)-2-(4-(piperidin-3-yl) phenyl)-2H-indazole-7-carboxamide ZEJULA), the epical formula is C19H20N4O, and molecular weight of 320.396 g/mol. (Fig.1) [19][20][21][22][23][24][25][26][27][28][29] Stock solution, calibration standards and quality control samples:Standard stock solutions of Niraparib and olaparib were prepared in methanol with a final concentration of 1.0 mg/mL. The IS stock solution was diluted to achieve a final concentration of 250 ng/mL in methanol.…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of Bioanalytical Method for Estimation of Niraparib in Rat Plasma Using High Performance LC-MS/MS And Its Application to Pharmacokinetic Study

Gullipalli¹,

Veeraraghavan²,

Kuna³

2020

IJAPB

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Inhibitor which is a novel ovarian cancer drug. For applicability to pharmacokinetic study, a LC-MS/MS based method for monitoring plasma levels of niraparib was developed. The analyte and Olaparib(IS) were chromatographed on YMC Pack ODS column C18 (50×4.6 mm i.d., 3µ) using MeOH:Ammonium Acetate (2 mM) as binary gradient mobile phase at flow rate 1mL/min with splitter (1:1) over 5 min RT. Detection of analytes were performed on LC-MS/MS system in SRM mode. The method was validated over concentration range of 4.38-1121.35 ng/mL and lower LOQ was 4.38 ng/mL for the analyte. Recoveries from spiked controls were >83% for the analyte and IS at all QC levels. Within batch and between batch accuracy for Niraparib was found within 94.2-105.8% and 98.9-102.0%. Within batch and between batch precision for niraparib was found <11.2% CV at all concentration levels. This method was successfully applied to monitor PK profile of niraparib on oral and IV administration to rats.

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Development and validation of an integrated LC-MS/MS assay for therapeutic drug monitoring of five PARP-inhibitors

Cited by 18 publications

References 31 publications

Bioanalytical Methods for Poly(ADP-Ribose) Polymerase Inhibitor Quantification: A Review for Therapeutic Drug Monitoring

Bioanalytical Methods for Poly(ADP-Ribose) Polymerase Inhibitor Quantification: A Review for Therapeutic Drug Monitoring

A Stability Indicating Reverse Phase-HPLC Method Development and Validation for the Estimation of Rucaparib in Bulk and Pharmaceutical Dosage Form

Development and Validation of Bioanalytical Method for Estimation of Niraparib in Rat Plasma Using High Performance LC-MS/MS And Its Application to Pharmacokinetic Study

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