Abstract
A rapid and sensitive LC–MS/MS method for the bioanalytical method development and validation for estimation of olanzapine in k3EDTA human plasma using Olanzapine D3 as internal standard has been developed and validated. The analytes and IS were extracted from plasma by solid phase extraction using Oasis HLB 1cc (30mg) Extraction Cartridge and separated on a Cosmosil, 5µm, C18 150*4. 6 mmcolumn using a 10 mM ammonium formate in Water: Acetonitrile (10: 90) at a flow rate of 1.0 mL/min. Detection involved an API-4000 LC–MS/MS with electrospray ionization in the positive ion mode and multiple-reaction monitoring for analysis. The method was validated according to FDA guidelines and shown to provide intra- and inter-day precision and accuracy within acceptable limits in a run time of only 4.0 min. The method was successfully applied to a pharmacokinetic study involving a single oral administration of a combination tablet to human male volunteers