title: A simple, selective and rapid validated method for estimation of anastrazole in human plasma by liquid chromatography-tandem mass spectrometry and its application to bioequivalence study.
abstract: A rapid, simple and specific method for estimation of anastrazole in human plasma was validated using letrozole as internal standard. The analyte and internal standard were extracted from plasma using simple solid-phase extraction. The compound were separated on a reverse-phase column with an isocratic mobile phase consisting of 0.1% formic acid in water and acetonitrile (12 : 88, v/v) and detected by tandem mass spectrometry in positive ion mode. The ion transitions recorded in multiple reaction monitoring mode were m/z 294.1 --> 225.1 for anastrazole and m/z 286.1 --> 217.1 for internal standard. Linearity in plasma was observed over the concentration range 0.3-30 ng/mL for anastrazole. The mean recovery for anastrazole was 83.7% with a lower limit of quantification of 0.3 ng/mL. The coefficient of variation of the assay was less than 6.8% and the accuracy was 96.1-102.2%. The validated method was applied to a bioequivalence study of 1 mg anastrazole tablet in healthy human volunteers.
authors.affiliation: School of Chemical Sciences, Swami Ramanand Teerth Marathwada University, Nanded, India. jangid_arvind@rediff mail.com
authors.forename: Arvind G
authors.initials: AG
authors.lastname: Jangid
authors.forename: Ashutosh M
authors.initials: AM
authors.lastname: Pudage
authors.forename: Santosh S
authors.initials: SS
authors.lastname: Joshi
authors.forename: Pramod N
authors.initials: PN
authors.lastname: Pabrekar
authors.forename: Rajesh H
authors.initials: RH
authors.lastname: Tale
authors.forename: Vikas V
authors.initials: VV
authors.lastname: Vaidya
mesh_terms: D000077384:Anastrozole; D018931:Antineoplastic Agents, Hormonal / Q000097:blood* / Q000493:pharmacokinetics*; D002853:Chromatography, Liquid / Q000379:methods*; D006801:Humans; D009570:Nitriles / Q000097:blood* / Q000493:pharmacokinetics*; D053719:Tandem Mass Spectrometry / Q000379:methods*; D013810:Therapeutic Equivalency; D014230:Triazoles / Q000097:blood* / Q000493:pharmacokinetics*
chemical_list: D018931:Antineoplastic Agents, Hormonal; D009570:Nitriles; D014230:Triazoles; D000077384:Anastrozole