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Development of UHPLC-MS/MS Method for Indirubin-3'-Oxime Derivative as a Novel FLT3 Inhibitor and Pharmacokinetic Study in Rats.
Molecules. 2020 Apr 27; 25(9)M

Abstract

This study aimed to develop and validate a sensitive liquid chromatography-coupled tandem mass spectrometry method for the quantification of LDD-2614, an indirubin derivative and novel FLT3 inhibitor, in rat plasma. In addition, the developed analytical method was applied to observe the pharmacokinetic properties of LDD-2614. Chromatographic separation was achieved on a Luna omega C18 column using a mixture of water and acetonitrile, both containing 0.1% formic acid. Quantitation was performed using positive electrospray ionization in a multiple reaction monitoring (MRM) mode. The MRM transitions were optimized as m/z 426.2→113.1 for LDD-2614 and m/z 390.2→113.1 for LDD-2633 (internal standard), and the lower limit of quantification (LLOQ) for LDD-2614 was determined as 0.1 ng/mL. Including the LLOQ, the nine-point calibration curve was linear with a correlation coefficient greater than 0.9991. Inter- and intraday accuracies (RE) ranged from -3.19% to 8.72%, and the precision was within 9.02%. All validation results (accuracy, precision, matrix effect, recovery, stability, and dilution integrity) met the acceptance criteria of the U.S. Food and Drug Administration and the Korea Ministry of Food and Drug Safety guidelines. The proposed method was validated and demonstrated to be suitable for the quantification of LDD-2614 for pharmacokinetics studies.

Authors+Show Affiliations

College of Pharmacy, Dankook University, Cheonan 31116, Korea.School of Life Sciences, Gwangju Institute of Science and Technology (GIST), Gwangju 61005, Korea.College of Pharmacy, Dankook University, Cheonan 31116, Korea.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32349415

Citation

Kim, Na Yoon, et al. "Development of UHPLC-MS/MS Method for Indirubin-3'-Oxime Derivative as a Novel FLT3 Inhibitor and Pharmacokinetic Study in Rats." Molecules (Basel, Switzerland), vol. 25, no. 9, 2020.
Kim NY, Kim YC, Kim YG. Development of UHPLC-MS/MS Method for Indirubin-3'-Oxime Derivative as a Novel FLT3 Inhibitor and Pharmacokinetic Study in Rats. Molecules. 2020;25(9).
Kim, N. Y., Kim, Y. C., & Kim, Y. G. (2020). Development of UHPLC-MS/MS Method for Indirubin-3'-Oxime Derivative as a Novel FLT3 Inhibitor and Pharmacokinetic Study in Rats. Molecules (Basel, Switzerland), 25(9). https://doi.org/10.3390/molecules25092039
Kim NY, Kim YC, Kim YG. Development of UHPLC-MS/MS Method for Indirubin-3'-Oxime Derivative as a Novel FLT3 Inhibitor and Pharmacokinetic Study in Rats. Molecules. 2020 Apr 27;25(9) PubMed PMID: 32349415.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development of UHPLC-MS/MS Method for Indirubin-3'-Oxime Derivative as a Novel FLT3 Inhibitor and Pharmacokinetic Study in Rats. AU - Kim,Na Yoon, AU - Kim,Yong-Chul, AU - Kim,Yoon Gyoon, Y1 - 2020/04/27/ PY - 2020/04/02/received PY - 2020/04/24/revised PY - 2020/04/26/accepted PY - 2020/5/1/entrez PY - 2020/5/1/pubmed PY - 2020/5/1/medline KW - LC-MS/MS KW - LDD-2614 KW - indirubin derivative KW - novel FLT3 inhibitor KW - pharmacokinetics JF - Molecules (Basel, Switzerland) JO - Molecules VL - 25 IS - 9 N2 - This study aimed to develop and validate a sensitive liquid chromatography-coupled tandem mass spectrometry method for the quantification of LDD-2614, an indirubin derivative and novel FLT3 inhibitor, in rat plasma. In addition, the developed analytical method was applied to observe the pharmacokinetic properties of LDD-2614. Chromatographic separation was achieved on a Luna omega C18 column using a mixture of water and acetonitrile, both containing 0.1% formic acid. Quantitation was performed using positive electrospray ionization in a multiple reaction monitoring (MRM) mode. The MRM transitions were optimized as m/z 426.2→113.1 for LDD-2614 and m/z 390.2→113.1 for LDD-2633 (internal standard), and the lower limit of quantification (LLOQ) for LDD-2614 was determined as 0.1 ng/mL. Including the LLOQ, the nine-point calibration curve was linear with a correlation coefficient greater than 0.9991. Inter- and intraday accuracies (RE) ranged from -3.19% to 8.72%, and the precision was within 9.02%. All validation results (accuracy, precision, matrix effect, recovery, stability, and dilution integrity) met the acceptance criteria of the U.S. Food and Drug Administration and the Korea Ministry of Food and Drug Safety guidelines. The proposed method was validated and demonstrated to be suitable for the quantification of LDD-2614 for pharmacokinetics studies. SN - 1420-3049 UR - https://www.unboundmedicine.com/medline/citation/32349415/Development_of_UHPLC_MS/MS_Method_for_Indirubin_3'_Oxime_Derivative_as_a_Novel_FLT3_Inhibitor_and_Pharmacokinetic_Study_in_Rats_ L2 - https://www.mdpi.com/resolver?pii=molecules25092039 DB - PRIME DP - Unbound Medicine ER -
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