title: Validated LC-MS-MS Method for Determination of SF0034 in Mice Plasma: Application to a Pharmacokinetic Study in Mice.
abstract: A rapid and sensitive assay method has been developed and validated using liquid chromatography coupled to tandem mass spectrometry with electrospray ionization in the positive-ion mode for the estimation of SF0034 in mice plasma. The assay procedure involves a simple protein precipitation of SF0034 and tolbutamide (internal standard, IS) from mice plasma. Chromatographic separation was performed on an Atlantis dC18 column using an isocratic mobile phase comprising 0.2% formic acid:acetonitrile (10:90, v/v) at a flow rate of 0.60 mL/min. The total run time was 2.5 min. For mass spectrometric detection, the multiple reaction monitoring was used and ion transitions monitored were m/z 322 → 248 for SF0034 and 271 → 155 for IS. Method validation was performed as per regulatory guidelines and the results met the acceptance criteria. A calibration curve was constructed in the range of 2.08-2,078 ng/mL. The intra- and inter-day precision was in the range of 1.06-14.4% and 7.16-11.7%, respectively. This novel method has been applied to a pharmacokinetic study in mice.
authors.affiliation: Drug Metabolism and Pharmacokinetics, Jubilant Biosys Ltd, Industrial Suburb, Yeshwanthpur, Bangalore 560022, India.
authors.forename: Umesh
authors.initials: U
authors.lastname: Todmal
authors.affiliation: Drug Metabolism and Pharmacokinetics, Jubilant Biosys Ltd, Industrial Suburb, Yeshwanthpur, Bangalore 560022, India.
authors.forename: P S
authors.initials: PS
authors.lastname: Suresh
authors.affiliation: Drug Metabolism and Pharmacokinetics, Jubilant Biosys Ltd, Industrial Suburb, Yeshwanthpur, Bangalore 560022, India.
authors.forename: Mohd
authors.initials: M
authors.lastname: Zainuddin
authors.affiliation: Drug Metabolism and Pharmacokinetics, Jubilant Biosys Ltd, Industrial Suburb, Yeshwanthpur, Bangalore 560022, India.
authors.forename: Ravi
authors.initials: R
authors.lastname: Kanth Bhamidipati
authors.affiliation: Department of Medicinal Chemistry, Jubilant Biosys Ltd, Industrial Suburb, Yeshwanthpur, Bangalore 560022, India.
authors.forename: Swapan Kumar
authors.initials: SK
authors.lastname: Samanta
authors.affiliation: Department of Medicinal Chemistry, Jubilant Biosys Ltd, Industrial Suburb, Yeshwanthpur, Bangalore 560022, India.
authors.forename: Gurulingappa
authors.initials: G
authors.lastname: Hallur
authors.affiliation: Department of Medicinal Chemistry, Jubilant Biosys Ltd, Industrial Suburb, Yeshwanthpur, Bangalore 560022, India.
authors.forename: Sridharan
authors.initials: S
authors.lastname: Rajagopal
authors.affiliation: Drug Metabolism and Pharmacokinetics, Jubilant Biosys Ltd, Industrial Suburb, Yeshwanthpur, Bangalore 560022, India.
authors.forename: Sriram
authors.initials: S
authors.lastname: Rajagopal
authors.affiliation: Drug Metabolism and Pharmacokinetics, Jubilant Biosys Ltd, Industrial Suburb, Yeshwanthpur, Bangalore 560022, India.
authors.forename: Ramesh
authors.initials: R
authors.lastname: Mullangi
mesh_terms: D000818:Animals; D002219:Carbamates / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics; D002853:Chromatography, Liquid / Q000379:methods*; D016014:Linear Models; D008297:Male; D051379:Mice; D008807:Mice, Inbred BALB C; D010655:Phenylenediamines / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D053719:Tandem Mass Spectrometry / Q000379:methods*
chemical_list: D002219:Carbamates; D010655:Phenylenediamines