title: Sensitive method for the determination of rocilinostat in small volume mouse plasma by LC-MS/MS and its application to a pharmacokinetic study in mice.
abstract: A highly sensitive, specific and rapid LC-ESI-MS/MS method has been developed and validated for the quantification of rocilinostat in small volume mouse plasma (20 μL) using vorinostat as an internal standard (IS) as per regulatory guidelines. Sample preparation was accomplished through a protein precipitation procedure with acetonitrile. Chromatography was achieved on Prodigy ODS-2 column using a binary gradient using mobile phase A (0.2% formic acid in water) and B (acetonitrile) at a flow rate of 0.38 mL/min. The total chromatographic run time was 4.1 min and the elution of rocilinostat and IS occurred at ~3.2 and 2.9 min, respectively. A linear response function was established in the concentration range of 0.28-1193 ng/mL in mouse plasma. The intra- and inter-day accuracy and precisions were in the ranges of 3.12-8.93 and 6.41-11.6%, respectively. This novel method has been applied to a pharmacokinetic study in mice. Copyright © 2016 John Wiley & Sons, Ltd.
authors.affiliation: Drug Metabolism and Pharmacokinetics, Jubilant Biosys Ltd, Industrial Suburb, Yeshwanthpur, Bangalore, -560 022, India.
authors.forename: Manish
authors.initials: M
authors.lastname: Gupta
authors.affiliation: Drug Metabolism and Pharmacokinetics, Jubilant Biosys Ltd, Industrial Suburb, Yeshwanthpur, Bangalore, -560 022, India.
authors.forename: Abhishek
authors.initials: A
authors.lastname: Dixit
authors.affiliation: Drug Metabolism and Pharmacokinetics, Jubilant Biosys Ltd, Industrial Suburb, Yeshwanthpur, Bangalore, -560 022, India.
authors.forename: V C
authors.initials: VC
authors.lastname: Devaraj
authors.affiliation: Drug Metabolism and Pharmacokinetics, Jubilant Biosys Ltd, Industrial Suburb, Yeshwanthpur, Bangalore, -560 022, India.
authors.forename: Mohd
authors.initials: M
authors.lastname: Zainuddin
authors.affiliation: Drug Metabolism and Pharmacokinetics, Jubilant Biosys Ltd, Industrial Suburb, Yeshwanthpur, Bangalore, -560 022, India.
authors.forename: Ravi Kanth
authors.initials: RK
authors.lastname: Bhamidipati
authors.affiliation: Department of Medicinal Chemistry, Jubilant Biosys Ltd, Industrial Suburb, Yeshwanthpur, Bangalore, -560 022, India.
authors.forename: Mahanandeesha S
authors.initials: MS
authors.lastname: Hallur
authors.affiliation: Department of Medicinal Chemistry, Jubilant Biosys Ltd, Industrial Suburb, Yeshwanthpur, Bangalore, -560 022, India.
authors.forename: Purushottam
authors.initials: P
authors.lastname: Dewang
authors.affiliation: Department of Medicinal Chemistry, Jubilant Biosys Ltd, Industrial Suburb, Yeshwanthpur, Bangalore, -560 022, India.
authors.forename: Sridharan
authors.initials: S
authors.lastname: Rajagopal
authors.affiliation: Drug Metabolism and Pharmacokinetics, Jubilant Biosys Ltd, Industrial Suburb, Yeshwanthpur, Bangalore, -560 022, India.
authors.forename: Sriram
authors.initials: S
authors.lastname: Rajagopal
authors.affiliation: Drug Metabolism and Pharmacokinetics, Jubilant Biosys Ltd, Industrial Suburb, Yeshwanthpur, Bangalore, -560 022, India.
authors.forename: Ramesh
authors.initials: R
authors.lastname: Mullangi
mesh_terms: D000818:Animals; D002853:Chromatography, Liquid / Q000379:methods*; D006877:Hydroxamic Acids / Q000097:blood*; D057230:Limit of Detection; D008297:Male; D051379:Mice; D008807:Mice, Inbred BALB C; D011743:Pyrimidines / Q000097:blood*; D053719:Tandem Mass Spectrometry / Q000379:methods*
chemical_list: D006877:Hydroxamic Acids; D011743:Pyrimidines; C572255:ricolinostat
keywords: LC-MS/MS; method validation; mouse plasma; pharmacokinetics; rocilinostat