Liquid chromatography–tandem mass spectrometric assay for the T790M mutant EGFR inhibitor osimertinib (AZD9291) in human plasma

Rood, Johannes J.M.; Bussel, Mark T J van; Schellens, Jan H.M.; Beijnen, Jos H.; Sparidans, Rolf W.

doi:10.1016/j.jchromb.2016.07.037

Cited by 41 publications

(47 citation statements)

References 7 publications

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“…However, this was not commercially available at the time, and therefore PAZO has been used as internal standard. For OSIM and PAZO the most abundant fragments were chosen (OSIM 500.3 → 72.3 and PAZO 438.2 → 357.1), which were similar to the transitions used in the study by Rood et al ().…”

Section: Resultsmentioning

confidence: 99%

“…As stability of OSIM at RT was considerably worse than described by Rood et al (), sample preparation was performed on dry‐ice to reduce degradation during sample preparation. It has been shown that OSIM is stable when stored on ice (Veerman et al, ).…”

Section: Resultsmentioning

confidence: 99%

“…The upper limit of quantification was set at 500 ng/ml, resulting in a calibration range from 25 to 500 ng/ml. In other studies, wider concentration ranges were used (between 0.5 and 4000 ng/ml) (Reis et al, ; Rood et al, ; Veerman et al, ; Zheng et al, ), but such a wide concentration range was considered unnecessary for this analytical method because the results in the planned follow‐up study are expected to be within the range of 25–500 ng/ml. Three calibration curves were constructed ( y = ax + b , weighting 1/ x ) and back‐calculated concentrations were not allowed to exceed 15% of the nominal value, except for the LLOQ, which was allowed to remain within 20% of the nominal value (Agency, ).…”

Section: Methodsmentioning

confidence: 99%

“…Seven liquid chromatography–tandem mass spectrometry (LC–MS/MS) methods to quantify OSIM in human plasma have previously been reported (Irie et al, ; Janssen et al, ; Mitchell, Bailey, Ewles, Swan, & Turpin, ; Reis et al, ; Rood, van Bussel, Schellens, Beijnen, & Sparidans, ; Veerman, Lam, Mathijssen, Koolen, & de Bruijn, ; Zheng et al, ). Four methods were single‐drug methods for OSIM (and its metabolites) (Irie et al, ; Mitchell et al, ; Rood et al, ; Zheng et al, ), while two other methods focused on simultaneous determination of multiple TKIs (Janssen et al, ; Reis et al, ; Veerman et al, ). Short‐term stability of OSIM has been evaluated in different types of plasma and in whole blood, but not one study evaluated OSIM stability in EDTA–plasma, heparinized plasma, human serum and whole blood, which makes it difficult to compare the stability results.…”

Section: Introductionmentioning

confidence: 99%

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Validation of an analytical method using HPLC–MS/MS to quantify osimertinib in human plasma and supplementary stability results

Veelen

Geel

Beer

et al. 2020

Biomedical Chromatography

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A new method for quantification of osimertinib (OSIM) in human plasma using a high‐performance liquid chromatography–tandem mass spectrometry method was developed and validated. Methanol was used for protein precipitation and pazopanib as internal standard. Separation was performed on a HyPURITY®C18 analytical column (50 × 2.1 mm; 3 μm) using a gradient elution of ammonium acetate in water and ammonium acetate in methanol, both acidified with formic acid 0.1%. Detection and quantification of OSIM and pazopanib was performed using a triple quadruple mass spectrometer after electrospray ionization. This method led to robust results, as the selectivity, carryover, precision and accuracy all met pre‐specified requirements. OSIM was stable in human serum when stored at −80°C. Reduced stability was found when stored at 2–4°C or room temperature. Degradation of OSIM slowed down in EDTA–plasma and acidified human serum. The limited stability of OSIM at room temperature should be considered for transport and sample preparation. Plasma samples should be frozen as soon as possible and sample preparation should be performed on dry‐ice. In the future, EDTA–plasma and sample acidification may be used to improve OSIM stability at room temperature. However, more research and validation of such an approach are required.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Validation of an analytical method using HPLC–MS/MS to quantify osimertinib in human plasma and supplementary stability results

Veelen

Geel

Beer

et al. 2020

Biomedical Chromatography

View full text Add to dashboard Cite

show abstract

“…For ceritinib, a LC-MS/MS assay has been published using acetonitrile and a saturated sodium chloride solution [22], for afatinib magnesium-chloride [79], and for osimertinib magnesium-sulfate was applied [87]. Other, non-TKI methods, make use of the salts ammonium-acetate, ammonium-formate, potassium-carbonate, and zinc-sulfate [71].…”

Section: Liquid-liquid Extractionmentioning

confidence: 99%

Recent developments in the chromatographic bioanalysis of approved kinase inhibitor drugs in oncology

Rood

Schellens

Beijnen

et al. 2016

Journal of Pharmaceutical and Biomedical Analysis

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Development and validation of a UPLC–MS/MS method for quantification of osimertinib (AZD9291) and its metabolite AZ5104 in human plasma

Zheng

Wei-cong

Zhang

et al. 2018

Biomedical Chromatography

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Osimertinib (AZD9291) is a highly selective irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) designed to treat nonsmall-cell lung cancer patients with EGFR active and T790 M resistant mutations. A rapid and sensitive method for quantitative analysis by ultra-performance liquid chromatography-tandem mass spectrometry of osimertinib and its metabolite AZ5104 in human plasma was developed and validated. The samples were prepared by protein precipitation and separated on a BEH C column (2.1 × 50 mm, 1.7 μm) by gradient elution with 0.1% (v/v) formic acid and 10 mm ammonium acetate in water and acetonitrile as the mobile phase. Electrospray ionization in positive ion mode and multiple reaction monitoring were used to monitor the ion transitions at m/z 500.4 → 385.3 and 486.3 → 371.1. The results indicated that the method had excellent sensitivity and specificity. The validation was performed in a range from 0.5 to 100 ng/mL. Intra-day and inter-day precisions (in terms of RSD) were all <15%, and the accuracies (in terms of RE) were within ±15%. The lower limit of quantification, matrix effect, extraction recovery, stability and dilution integrity were also validated and satisfied the validation criteria. Finally, this method was successfully applied in a retrospective analysis, and the predose samples of 52 nonsmall-cell lung cancer patients who were enrolled in a novel third EGFR TKI clinical trial were analyzed for screening regardless of whether they had previously received osimertinib treatments.

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Liquid chromatography–tandem mass spectrometric assay for the T790M mutant EGFR inhibitor osimertinib (AZD9291) in human plasma

Cited by 41 publications

References 7 publications

Validation of an analytical method using HPLC–MS/MS to quantify osimertinib in human plasma and supplementary stability results

Validation of an analytical method using HPLC–MS/MS to quantify osimertinib in human plasma and supplementary stability results

Recent developments in the chromatographic bioanalysis of approved kinase inhibitor drugs in oncology

Development and validation of a UPLC–MS/MS method for quantification of osimertinib (AZD9291) and its metabolite AZ5104 in human plasma

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