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

✍ Scribed by Arvind G. Jangid; Ashutosh M. Pudage; Santosh S. Joshi; Pramod N. Pabrekar; Rajesh H. Tale; Vikas V. Vaidya

• Publisher: John Wiley and Sons
• Year: 2009
• Tongue: English
• Weight: 262 KB
• Volume: 24
• Category: Article
• ISSN: 0269-3879
• DOI: 10.1002/bmc.1354

✦ Synopsis

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. Copyright © 2009 John Wiley & Sons, Ltd.