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Izvorni znanstveni članak
https://doi.org/10.5599/admet.557

Development and validation of a novel method for simultaneous quantification of enzalutamide, darolutamide and their active metabolites in mice dried blood spots using LC-MS/MS: application to pharmacokinetic study in mice

Neraj Kumar Saini ; Drug Metabolism and Pharmacokinetics, Jubilant Biosys, Industrial Suburb, Yeshwanthpur, Bangalore-560 022, India
Suresh P. Sulochana ; Drug Metabolism and Pharmacokinetics, Jubilant Biosys, Industrial Suburb, Yeshwanthpur, Bangalore-560 022, India
Mohd Zainuddin ; Drug Metabolism and Pharmacokinetics, Jubilant Biosys, Industrial Suburb, Yeshwanthpur, Bangalore-560 022, India
Ramesh Mullangi ; Drug Metabolism and Pharmacokinetics, Jubilant Biosys, Industrial Suburb, Yeshwanthpur, Bangalore-560 022, India

Puni tekst: engleski, pdf (1 MB) str. 242-257 preuzimanja: 220* citiraj
APA 6th Edition
Saini, N.K., Sulochana, S.P., Zainuddin, M. i Mullangi, R. (2018). Development and validation of a novel method for simultaneous quantification of enzalutamide, darolutamide and their active metabolites in mice dried blood spots using LC-MS/MS: application to pharmacokinetic study in mice. ADMET and DMPK, 6 (3), 242-257. https://doi.org/10.5599/admet.557
MLA 8th Edition
Saini, Neraj Kumar, et al. "Development and validation of a novel method for simultaneous quantification of enzalutamide, darolutamide and their active metabolites in mice dried blood spots using LC-MS/MS: application to pharmacokinetic study in mice." ADMET and DMPK, vol. 6, br. 3, 2018, str. 242-257. https://doi.org/10.5599/admet.557. Citirano 13.11.2019.
Chicago 17th Edition
Saini, Neraj Kumar, Suresh P. Sulochana, Mohd Zainuddin i Ramesh Mullangi. "Development and validation of a novel method for simultaneous quantification of enzalutamide, darolutamide and their active metabolites in mice dried blood spots using LC-MS/MS: application to pharmacokinetic study in mice." ADMET and DMPK 6, br. 3 (2018): 242-257. https://doi.org/10.5599/admet.557
Harvard
Saini, N.K., et al. (2018). 'Development and validation of a novel method for simultaneous quantification of enzalutamide, darolutamide and their active metabolites in mice dried blood spots using LC-MS/MS: application to pharmacokinetic study in mice', ADMET and DMPK, 6(3), str. 242-257. https://doi.org/10.5599/admet.557
Vancouver
Saini NK, Sulochana SP, Zainuddin M, Mullangi R. Development and validation of a novel method for simultaneous quantification of enzalutamide, darolutamide and their active metabolites in mice dried blood spots using LC-MS/MS: application to pharmacokinetic study in mice. ADMET and DMPK [Internet]. 2018 [pristupljeno 13.11.2019.];6(3):242-257. https://doi.org/10.5599/admet.557
IEEE
N.K. Saini, S.P. Sulochana, M. Zainuddin i R. Mullangi, "Development and validation of a novel method for simultaneous quantification of enzalutamide, darolutamide and their active metabolites in mice dried blood spots using LC-MS/MS: application to pharmacokinetic study in mice", ADMET and DMPK, vol.6, br. 3, str. 242-257, 2018. [Online]. https://doi.org/10.5599/admet.557

Sažetak
A simple, sensitive and rapid assay method has been developed and validated for the estimation of enzalutamide, N-desmethylenzalutamide (active metabolite of enzalutamide), darolutamide and ORM-15341 (active metabolite of darolutamide) on mice dried blood spots (DBS) using liquid chromatography coupled to tandem mass spectrometry with electro spray ionization in the positive-ion mode. The method utilizes liquid extraction of enzalutamide, N-desmethylenzalutamide, darolutamide and ORM-15341 from 3 mm punched disks from DBS cards (spiked or study samples). The extracted sample was chromatographed using an isocratic mobile phase (0.2 % formic acid : acetonitrile; 30:70, v/v) on an Atlantis dC18 column. The total run time was 2.5 min. The MS/MS ion transitions monitored were m/z 465 → m/z 209, m/z 451 → m/z 195, m/z 399 → m/z 178, m/z 397 → m/z 194 and m/z 481 → m/z 453 for enzalutamide, N-desmethyl¬enzalutamide, darolutamide, ORM-15341 and the IS (apalutamide-d3), respectively. Method validation was performed as per regulatory guideline. The assay had a good linearity over the range of 0.93-2000 ng/mL. The intra- and inter-batch accuracy and precision (%RE & RSD) across quality controls met the acceptance criteria for all the analytes. Stability studies showed that all the analytes were stable on DBS cards for one month. This novel method has been applied to analyze the DBS samples of enzalutamide, N-desmethylenzalutamide, darolutamide and ORM-15341 obtained from a pharmacokinetic study in mice.

Ključne riječi
Enzalutamide; N-desmethylenzalutamide; darolutamide; ORM-15341; dried blood spot; LC-MS/MS; method validation; mice; pharmacokinetics

Hrčak ID: 205905

URI
https://hrcak.srce.hr/205905

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