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Simultaneous determination of selected tyrosine kinase inhibitors with corticosteroids and antiemetics in rat plasma by solid phase extraction and ultra-performance liquid chromatography-tandem mass spectrometry: Application to pharmacokinetic interaction studies.
J Pharm Biomed Anal 2016; 124:216-227JP

Abstract

A sensitive and selective ultra-performance liquid chromatography-tandem mass spectrometry method has been developed and validated for the simultaneous analysis of selected tyrosine kinase inhibitors (TKIs)(gefitinib GEF, erlotinib ERL), corticosteroids (dexamethasone DEX, prednisolone PRED), and the antiemetic ondansetron (OND) in rat plasma samples. After the addition of domperidone (DOM) as internal standard (IS), spiked plasma samples were prepared using the solid phase extraction (SPE) C 18 cartridges. Chromatographic separation was performed on a Waters BEH C18 column with an isocratic elution using a mobile phase composed of acetonitrile and water, each with 0.1% formic acid, (80: 20, v/v), at a flow rate of 0.2 mL/min. Quantitation of the analytes was performed using the multiple reaction monitoring (MRM) mode with the positive ionization mode at m/z 447.25>128.08 (GEF), m/z 394.20>278.04 (ERL), m/z 393.30>147.04 (DEX), m/z 361.29>147.02 (PRED), m/z 294.18>170.16 (OND), and m/z 426.26>175.07 (DOM). The method was validated over the concentration range of 0.025-100 (GEF, ERL, OND) and 0.05-100 ng/mL plasma (PRED, DEX) with very low lower limit of quantification of 0.025 (GEF, ERL, OND) and 0.05 ng/mL (DEX, PRED). The intra- and inter-day precision (RSD%) evaluated at four different concentration levels were within the acceptable limits (<15%). The method provided good extraction recovery of all analytes from rat plasma (Er% from -14.05 to -1.08). The validated method was successfully applied to the pharmacokinetic studies following the oral administration of selected combinations of the studied drugs. This study can be readily applied in therapeutic drug monitoring (TDM) in patients receiving these drug combinations as well as investigation of possible drug interactions between TKIs and DEX/PRED/OND.

Authors+Show Affiliations

College of Pharmacy, Department of Pharmaceutical Chemistry, King Saud University, Riyadh 11495, P.O. Box 22452, Saudi Arabia; Faculty of Pharmacy, Department of Pharmaceutical Analytical Chemistry, University of Alexandria, El-Messalah, Alexandria 21521, Egypt. Electronic address: hadirrona@yahoo.com.College of Pharmacy, Department of Pharmaceutical Chemistry, King Saud University, Riyadh 11495, P.O. Box 22452, Saudi Arabia.College of Pharmacy, Department of Pharmaceutical Chemistry, King Saud University, Riyadh 11495, P.O. Box 22452, Saudi Arabia.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't
Validation Studies

Language

eng

PubMed ID

26966895

Citation

Maher, Hadir M., et al. "Simultaneous Determination of Selected Tyrosine Kinase Inhibitors With Corticosteroids and Antiemetics in Rat Plasma By Solid Phase Extraction and Ultra-performance Liquid Chromatography-tandem Mass Spectrometry: Application to Pharmacokinetic Interaction Studies." Journal of Pharmaceutical and Biomedical Analysis, vol. 124, 2016, pp. 216-227.
Maher HM, Alzoman NZ, Shehata SM. Simultaneous determination of selected tyrosine kinase inhibitors with corticosteroids and antiemetics in rat plasma by solid phase extraction and ultra-performance liquid chromatography-tandem mass spectrometry: Application to pharmacokinetic interaction studies. J Pharm Biomed Anal. 2016;124:216-227.
Maher, H. M., Alzoman, N. Z., & Shehata, S. M. (2016). Simultaneous determination of selected tyrosine kinase inhibitors with corticosteroids and antiemetics in rat plasma by solid phase extraction and ultra-performance liquid chromatography-tandem mass spectrometry: Application to pharmacokinetic interaction studies. Journal of Pharmaceutical and Biomedical Analysis, 124, pp. 216-227. doi:10.1016/j.jpba.2016.03.013.
Maher HM, Alzoman NZ, Shehata SM. Simultaneous Determination of Selected Tyrosine Kinase Inhibitors With Corticosteroids and Antiemetics in Rat Plasma By Solid Phase Extraction and Ultra-performance Liquid Chromatography-tandem Mass Spectrometry: Application to Pharmacokinetic Interaction Studies. J Pharm Biomed Anal. 2016 May 30;124:216-227. PubMed PMID: 26966895.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Simultaneous determination of selected tyrosine kinase inhibitors with corticosteroids and antiemetics in rat plasma by solid phase extraction and ultra-performance liquid chromatography-tandem mass spectrometry: Application to pharmacokinetic interaction studies. AU - Maher,Hadir M, AU - Alzoman,Nourah Z, AU - Shehata,Shereen M, Y1 - 2016/03/05/ PY - 2016/02/02/received PY - 2016/02/27/revised PY - 2016/03/03/accepted PY - 2016/3/12/entrez PY - 2016/3/12/pubmed PY - 2017/1/12/medline KW - Antiemetics KW - Corticosteroids KW - Pharmacokinetics KW - Rat plasma KW - Tyrosine kinase inhibitors KW - UPLC–MS/MS SP - 216 EP - 227 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 124 N2 - A sensitive and selective ultra-performance liquid chromatography-tandem mass spectrometry method has been developed and validated for the simultaneous analysis of selected tyrosine kinase inhibitors (TKIs)(gefitinib GEF, erlotinib ERL), corticosteroids (dexamethasone DEX, prednisolone PRED), and the antiemetic ondansetron (OND) in rat plasma samples. After the addition of domperidone (DOM) as internal standard (IS), spiked plasma samples were prepared using the solid phase extraction (SPE) C 18 cartridges. Chromatographic separation was performed on a Waters BEH C18 column with an isocratic elution using a mobile phase composed of acetonitrile and water, each with 0.1% formic acid, (80: 20, v/v), at a flow rate of 0.2 mL/min. Quantitation of the analytes was performed using the multiple reaction monitoring (MRM) mode with the positive ionization mode at m/z 447.25>128.08 (GEF), m/z 394.20>278.04 (ERL), m/z 393.30>147.04 (DEX), m/z 361.29>147.02 (PRED), m/z 294.18>170.16 (OND), and m/z 426.26>175.07 (DOM). The method was validated over the concentration range of 0.025-100 (GEF, ERL, OND) and 0.05-100 ng/mL plasma (PRED, DEX) with very low lower limit of quantification of 0.025 (GEF, ERL, OND) and 0.05 ng/mL (DEX, PRED). The intra- and inter-day precision (RSD%) evaluated at four different concentration levels were within the acceptable limits (<15%). The method provided good extraction recovery of all analytes from rat plasma (Er% from -14.05 to -1.08). The validated method was successfully applied to the pharmacokinetic studies following the oral administration of selected combinations of the studied drugs. This study can be readily applied in therapeutic drug monitoring (TDM) in patients receiving these drug combinations as well as investigation of possible drug interactions between TKIs and DEX/PRED/OND. SN - 1873-264X UR - https://www.unboundmedicine.com/medline/citation/26966895/Simultaneous_determination_of_selected_tyrosine_kinase_inhibitors_with_corticosteroids_and_antiemetics_in_rat_plasma_by_solid_phase_extraction_and_ultra_performance_liquid_chromatography_tandem_mass_spectrometry:_Application_to_pharmacokinetic_interaction_studies_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0731-7085(16)30131-5 DB - PRIME DP - Unbound Medicine ER -