title: Quantitative determination of saroglitazar, a predominantly PPAR alpha agonist, in human plasma by a LC-MS/MS method utilizing electrospray ionization in a positive mode.
abstract: A sensitive LC-MS/MS method was developed and validated for quantitation of saroglitazar using turboion spray interface with positive ion mode. A liquid-liquid extraction, with a mixture of dichloromethane and diethyl ether, was employed for the extraction of saroglitazar and glimepiride (IS) from human plasma. The chromatographic separation was achieved using an ACE-5, C18(4.6 × 100 mm) column with a gradient mobile phase comprising acetonitrile and ammonium acetate buffer with trifluoracetic acid in purified water. Both analytes were separated within 10 min with retention times of 4.52 and 2.57 min for saroglitazar and IS, respectively. Saroglitazar quantitation was achieved by the summation of two MRM transition pairs (m/z 440.2 to m/z 366.0 and m/z 440.2 to m/z 183.1), while that of IS was achieved using transition pair m/z 491.3 to m/z 352.0. The calibration standards of saroglitazar showed linearity from 0.2 to 500 ng/mL, with a lower limit of quantitation of 0.2 ng/mL. The biases for inter- and intra-batch assays were -7.51-1.15% and -11.21 to -3.25%, respectively, while the corresponding precisions were 5.04-8.06% and 1.53-7.68%, respectively. The developed method was used to monitor the plasma concentrations of saroglitazar in clinical samples.
authors.affiliation: Zydus Research Centre, Bioanalytical Laboratory, Ahmedabad, -382 210, Gujarat, India.
authors.forename: Ashok
authors.initials: A
authors.lastname: Ghoghari
authors.affiliation: Zydus Research Centre, Bioanalytical Laboratory, Ahmedabad, -382 210, Gujarat, India.
authors.forename: Ranjeet
authors.initials: R
authors.lastname: Dash
authors.affiliation: Zydus Research Centre, Bioanalytical Laboratory, Ahmedabad, -382 210, Gujarat, India.
authors.forename: Chandrakant
authors.initials: C
authors.lastname: Bhatt
authors.affiliation: Zydus Research Centre, Bioanalytical Laboratory, Ahmedabad, -382 210, Gujarat, India.
authors.forename: Kanchan
authors.initials: K
authors.lastname: Singh
authors.affiliation: Zydus Research Centre, Bioanalytical Laboratory, Ahmedabad, -382 210, Gujarat, India.
authors.forename: Anil
authors.initials: A
authors.lastname: Jha
authors.affiliation: Zydus Research Centre, Bioanalytical Laboratory, Ahmedabad, -382 210, Gujarat, India.
authors.forename: Harilal
authors.initials: H
authors.lastname: Patel
authors.affiliation: Zydus Research Centre, Clinical Research, Ahmedabad, -382 210, Gujarat, India.
authors.forename: Rahul
authors.initials: R
authors.lastname: Gupta
authors.affiliation: Zydus Research Centre, Clinical Research, Ahmedabad, -382 210, Gujarat, India.
authors.forename: Kevinkumar
authors.initials: K
authors.lastname: Kansagra
authors.affiliation: Zydus Research Centre, Bioanalytical Laboratory, Ahmedabad, -382 210, Gujarat, India.
authors.forename: Nuggehally R
authors.initials: NR
authors.lastname: Srinivas
mesh_terms: D002138:Calibration; D002853:Chromatography, Liquid / Q000379:methods*; D006801:Humans; D057230:Limit of Detection; D047493:PPAR alpha / Q000819:agonists*; D010666:Phenylpropionates / Q000097:blood*; D011758:Pyrroles / Q000097:blood*; D012015:Reference Standards; D015203:Reproducibility of Results; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods*; D053719:Tandem Mass Spectrometry / Q000379:methods*
chemical_list: D047493:PPAR alpha; D010666:Phenylpropionates; D011758:Pyrroles; C000588741:saroglitazar
keywords: LC-MS/MS; Lipaglyn™; PPAR-α; method validation; pharmacokinetics; plasma; saroglitazar