First electrochemical investigation of new generation antineoplastic agent ceritinib at a boron-doped diamond electrode based on the pre-enrichment effect of anionic surfactant

Pınar, Pınar Talay; Uzun, Gökhan; Şentürk, Zühre

doi:10.1007/s13738-023-02792-z

Cited by 2 publications

(2 citation statements)

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“…Principally, the microwell methods assisted with microplate readers align with the principles of green analytical chemistry (GAC) by downsizing analytical processes [12,13,15]. This approach offers numerous benefits compared to traditional spectrophotometric methods that employ volumetric flasks and cuvettes.…”

Section: Greenness Levels Of the Mw-spmsmentioning

confidence: 99%

“…There are limited analytical methods available for characterizing and quantifying CER in bulk drug or capsules. These methods include liquid chromatography coupled with an ultraviolet detector (HPLC-UV) [9,10] or a tandem mass spectrometric detector (LC-MS/MS) [11], and voltammetry [12]. HPLC-UV methods were primarily developed for stability testing of CER, whereas LC-MS/MS methods were designed for quantifying While CER has shown significant clinical benefits, it is also associated with certain adverse events, including gastrointestinal disturbances, hepatotoxicity, fatigue, and edema.…”

Section: Introductionmentioning

confidence: 99%

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Three Innovative Green and High-Throughput Microwell Spectrophotometric Methods for the Quantitation of Ceritinib, a Potent Drug for the Treatment of ALK-Positive Non-Small Cell Lung Cancer: An Application to the Analysis of Capsules and Drug Uniformity Testing

Abuhejail,

Alzoman,

Darwish

2023

Molecules

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Ceritinib (CER) is a potent drug that has been recently approved by the Food and Drug Administration for the treatment of patients with non-small cell lung cancer harboring the anaplastic lymphoma kinase mutation gene. The existing methods for the quality control of CER are very limited and suffer from limited analytical throughput and do not meet the requirements of the green analytical principles. This study presented the first-ever development and validation of three innovative green and high-throughput microwell spectrophotometric methods (MW-SPMs) for the quality control of CER in its dosage form (Zykadia® capsules). These MW-SPMs were based on the formation of colored N-vinylamino-substituted haloquinone derivatives of CER upon its reactions with each of chloranil, bromanil, and 2,3-dichloro-1,4-naphthoquinone in the presence of acetaldehyde. The optimized procedures of the MW-SPMs were established, and their analytical performances were validated according to the ICH. The linear range of the MW-SPMs was 5–150 µg/mL, with limits of quantitation of 5.3–7.6 µg/mL. The accuracy and precision of the MW-SPMs were proved, as the average recovery values were 99.9–101.0%, and the relative standard deviations did not exceed 1.8%. The three methods were applied to the determination of CER content in Zykadia® capsules and drug content uniformity testing. The greenness of the MW-SPMs was proved using three different metric tools. In addition, these methods encompassed the advantage of high-throughput analysis. In conclusion, the three methods are valuable tools for convenient and reliable application in the pharmaceutical quality control units for CER-containing capsules.

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Section: Greenness Levels Of the Mw-spmsmentioning

confidence: 99%