2. Academic Validation
  3. Determination of ulixertinib in mice plasma by LC-MS/MS and its application to a pharmacokinetic study in mice

Determination of ulixertinib in mice plasma by LC-MS/MS and its application to a pharmacokinetic study in mice

  • J Pharm Biomed Anal. 2016 Jun 5;125:140-4. doi: 10.1016/j.jpba.2016.03.036.
Rajinish Kumar 1,  P S Suresh 1,  G Rudresh 1,  Mohd Zainuddin 1,  Purushottam Dewang 2,  Ragahava Reddy Kethiri 2,  Sriram Rajagopal 1,  Ramesh Mullangi 3
Affiliations

Affiliations

  • 1 Jubilant Biosys Ltd., Industrial Suburb, Yeshwanthpur, Bangalore 560 022, India.
  • 2 Medicinal Chemistry, Jubilant Biosys Ltd., Industrial Suburb, Yeshwanthpur, Bangalore 560 022, India.
  • 3 Jubilant Biosys Ltd., Industrial Suburb, Yeshwanthpur, Bangalore 560 022, India. Electronic address: [email protected].
PMID: 27017572 DOI: 10.1016/j.jpba.2016.03.036
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.

Keywords

LC–MS/MS; Method validation; Mice plasma; Pharmacokinetics; Ulixertinib.

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