title: Determination of ulixertinib in mice plasma by LC-MS/MS and its application to a pharmacokinetic study in mice.
abstract: A sensitive, specific and rapid LC-ESI-MS/MS method has been developed and validated for the quantification of ulixertinib in mice plasma using phenacetin as an internal standard (I.S.) as per regulatory guidelines. Sample preparation was accomplished through a protein precipitation procedure with acetonitrile:methanol mixture. Chromatographic separation was performed on Atlantis dC18 column using a binary gradient using mobile phase A (0.2% formic acid in water) and B (acetonitrile) at a flow rate of 0.60mL/min. Elution of ulixertinib and I.S. occurred at ∼1.07 and 1.20min, respectively. The total chromatographic run time was 2.5min. A linear response function was established in the concentration range of 1.58-2054ng/mL. The intra- and inter-day accuracy and precisions were in the range of 2.11-11.8 and 5.80-11.4%, respectively. This novel method has been applied to a pharmacokinetic study in mice.
authors.affiliation: Jubilant Biosys Ltd., Industrial Suburb, Yeshwanthpur, Bangalore 560 022, India.
authors.forename: Rajinish
authors.initials: R
authors.lastname: Kumar
authors.affiliation: Jubilant Biosys Ltd., Industrial Suburb, Yeshwanthpur, Bangalore 560 022, India.
authors.forename: P S
authors.initials: PS
authors.lastname: Suresh
authors.affiliation: Jubilant Biosys Ltd., Industrial Suburb, Yeshwanthpur, Bangalore 560 022, India.
authors.forename: G
authors.initials: G
authors.lastname: Rudresh
authors.affiliation: Jubilant Biosys Ltd., Industrial Suburb, Yeshwanthpur, Bangalore 560 022, India.
authors.forename: Mohd
authors.initials: M
authors.lastname: Zainuddin
authors.affiliation: Medicinal Chemistry, Jubilant Biosys Ltd., Industrial Suburb, Yeshwanthpur, Bangalore 560 022, India.
authors.forename: Purushottam
authors.initials: P
authors.lastname: Dewang
authors.affiliation: Medicinal Chemistry, Jubilant Biosys Ltd., Industrial Suburb, Yeshwanthpur, Bangalore 560 022, India.
authors.forename: Ragahava Reddy
authors.initials: RR
authors.lastname: Kethiri
authors.affiliation: Jubilant Biosys Ltd., Industrial Suburb, Yeshwanthpur, Bangalore 560 022, India.
authors.forename: Sriram
authors.initials: S
authors.lastname: Rajagopal
authors.affiliation: Jubilant Biosys Ltd., Industrial Suburb, Yeshwanthpur, Bangalore 560 022, India. Electronic address: mullangi_ramesh@jubilantinnovation.com.
authors.forename: Ramesh
authors.initials: R
authors.lastname: Mullangi
mesh_terms: D000631:Aminopyridines / Q000097:blood* / Q000493:pharmacokinetics*; D000818:Animals; D002853:Chromatography, Liquid / Q000379:methods*; D057230:Limit of Detection; D008297:Male; D051379:Mice; D008807:Mice, Inbred BALB C; D011758:Pyrroles / Q000097:blood* / Q000493:pharmacokinetics*; D015203:Reproducibility of Results; D053719:Tandem Mass Spectrometry / Q000379:methods*
chemical_list: D000631:Aminopyridines; D011758:Pyrroles; C000618314:ulixertinib
keywords: LC–MS/MS; Method validation; Mice plasma; Pharmacokinetics; Ulixertinib