Development and Validation of a Quantitative LC-MS/MS Method for CDK4/6 Inhibitors Palbociclib, Ribociclib, Abemaciclib, and Abemaciclib-M2 in Human Plasma

Burke, Sarah; Kamal, Mustafa; Goey, Andrew K.L.

doi:10.1097/ftd.0000000000001063

Cited by 6 publications

(15 citation statements)

References 19 publications

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“…This demonstrates the necessity of using an internal standard during ribociclib quantification. For example, Burke and colleagues developed a recent LC‐MS/MS assay for measuring CDK4/6 inhibitors in human plasma and utilized ribociclib‐D6 as an internal standard 12 . The assay revealed a signal suppression for the internal standard, but the normalized matrix effect of the analyte (ribociclib) was acceptable 12 …”

Section: Resultsmentioning

confidence: 99%

“…12 The assay revealed a signal suppression for the internal standard, but the normalized matrix effect of the analyte (ribociclib) was acceptable. 12…”

Section: Extraction Recovery and Matrix Effectmentioning

confidence: 91%

“…overall matrix effect, similar to previous investigations. 12,13,16 This demonstrates the necessity of using an internal standard during ribociclib quantification. For example, Burke and colleagues developed a recent LC-MS/MS assay for measuring CDK4/6 inhibitors in human plasma and utilized ribociclib-D6 as an internal standard.…”

Section: Extraction Recovery and Matrix Effectmentioning

confidence: 95%

“…The current assay has a shorter run time than previously published methods in human plasma, which reported a run time of 8-20 min. 12,16,20 However, the later assays included more than one CDK4/6 inhibitor in the same analysis, and our assay measured only ribociclib. Other analytical assays have also reported a chromatographic separation of CDK4/6 inhibitors within 4-6.5 min.…”

Section: Sample Preparation and Lc-ms/ms Optimizationmentioning

confidence: 99%

“…The analytical methods that reported quantification of ribociclib in biological matrices were based on liquid chromatography-tandem mass spectrometry (LC-MS/MS) and primarily developed and validated in human plasma. [11][12][13][14][15][16][17][18][19][20] One study quantified ribociclib in human dried blood spots. 21 Two other analytical methods determined ribociclib in mouse plasma.…”

Section: Introductionmentioning

confidence: 99%

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Simple and rapid quantification of ribociclib in rat plasma by protein precipitation and LC‐MS/MS: An application to pharmacokinetics of ribociclib nanoparticles in rats

Alshogran,

Al‐Shdefat,

Hailat

2023

J Mass Spectrom

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Ribociclib is a cyclin‐dependent kinase (CDK4/6) inhibitor and is a standard of care for treating metastatic breast cancer. The drug has moderate oral bioavailability and exhibits permeability‐controlled absorption. Novel formulations to enhance ribociclib pharmacokinetics are being developed and tested in rats. This requires developing analytical assays for quantifying ribociclib monitoring in rat plasma. We present a fully validated, sensitive, and simple LC‐MS/MS method for measuring ribociclib in rat plasma. Ribociclib‐D6 was utilized as an internal standard, and a simple protein precipitation procedure with acetonitrile was used in sample preparation. Excellent assay linearity was observed over a standard curve concentration of 1.008–1027.624 ng/mL. Acceptable intra‐ and inter‐day accuracy and reproductivity were demonstrated for ribociclib quality controls (bias and CV% within ±15%). Complete extraction recovery of ribociclib was achieved, and a negligible matrix effect of analyte to internal standard ratio was observed. Ribociclib was stable at various conditions, including bench‐top, freeze–thaw, and short‐term stability. Overall, the presented method is simple, sensitive, accurate, and precise and was successfully applied to quantify ribociclib in plasma samples from a pharmacokinetic study of ribociclib suspension and nanoparticle formulation in rats.

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Section: Resultsmentioning

confidence: 99%

“…12 The assay revealed a signal suppression for the internal standard, but the normalized matrix effect of the analyte (ribociclib) was acceptable. 12…”

Section: Extraction Recovery and Matrix Effectmentioning

confidence: 91%

Section: Extraction Recovery and Matrix Effectmentioning

confidence: 95%

Section: Sample Preparation and Lc-ms/ms Optimizationmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Simple and rapid quantification of ribociclib in rat plasma by protein precipitation and LC‐MS/MS: An application to pharmacokinetics of ribociclib nanoparticles in rats

Alshogran,

Al‐Shdefat,

Hailat

2023

J Mass Spectrom

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Dispersive liquid-liquid microextraction followed by sweeping micellar electrokinetic chromatography-tandem mass spectrometry for determination of six breast cancer drugs in human plasma

Mlinarić,

Turković,

Sertić

2024

Journal of Chromatography A

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Recent Contributions of Mass Spectrometry-Based “Omics” in the Studies of Breast Cancer

Banerjee,

Hatimuria,

Sarkar

et al. 2023

Chem. Res. Toxicol.

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Breast cancer (BC) is one of the most heterogeneous groups of cancer. As every biotype of BC is unique and presents a particular "omic" signature, they are increasingly characterized nowadays with novel mass spectrometry (MS) strategies. BC therapeutic approaches are primarily based on the two features of human epidermal growth factor receptor 2 (HER2) and estrogen receptor (ER) positivity. Various strategic MS implementations are reported in studies of BC also involving data independent acquisitions (DIAs) of MS which report novel differential proteomic, lipidomic, proteogenomic, phosphoproteomic, and metabolomic characterizations associated with the disease and its therapeutics. Recently many "omic" studies have aimed to identify distinct subsidiary biotypes for diagnosis, prognosis, and targets of treatment. Along with these, drug-induced-resistance phenotypes are characterized by "omic" changes. These identifying aspects of the disease may influence treatment outcomes in the near future. Drug quantifications and characterizations are also done regularly and have implications in therapeutic monitoring and in drug efficacy assessments. We report these studies, mentioning their implications toward the understanding of BC. We briefly provide the MS instrumentation principles that are adopted in such studies as an overview with a brief outlook on DIA-MS strategies. In all of these, we have chosen a model cancer for its revelations through MS-based "omics".

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Development and Validation of a Quantitative LC-MS/MS Method for CDK4/6 Inhibitors Palbociclib, Ribociclib, Abemaciclib, and Abemaciclib-M2 in Human Plasma

Abstract: Supplemental Digital Content is Available in the Text.

Cited by 6 publications

References 19 publications

Simple and rapid quantification of ribociclib in rat plasma by protein precipitation and LC‐MS/MS: An application to pharmacokinetics of ribociclib nanoparticles in rats

Simple and rapid quantification of ribociclib in rat plasma by protein precipitation and LC‐MS/MS: An application to pharmacokinetics of ribociclib nanoparticles in rats

Dispersive liquid-liquid microextraction followed by sweeping micellar electrokinetic chromatography-tandem mass spectrometry for determination of six breast cancer drugs in human plasma

Recent Contributions of Mass Spectrometry-Based “Omics” in the Studies of Breast Cancer

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