Amber Awad | Authors


Validation of LC–MS-MS Methods for the Determination of Ibuprofen in Miniature Swine Plasma and Synovial Fluid

Published methods for the determination of ibuprofen in biological fluids by liquid chromatography (LC)–UV or LC–mass spectrometry (MS)-MS have quantitation ranges consistent with the relatively high but typical ibuprofen dose (200–800 mg), generally having lower limits of quantitation in the low micrograms-per-milliliter range. For the analysis of plasma and synovial fluid samples from preclinical (miniature swine) studies utilizing a novel ibuprofen dosage form, LC–MS-MS methods were developed and validated over the 10–1000 ng/mL range. Ibuprofen undergoes biotransformation to ibuprofen acyl glucuronide and sublimes under routine bioanalytical sample handling conditions. Procedures were implemented to minimize the impact of these potential liabilities.

Charged Aerosol Detection in Pharmaceutical Analysis: An Overview

Over the past several years, charged aerosol detection (CAD) has become a widely used technology in the pharmaceutical laboratory. From formulation to stability and even quality control, many analysts are turning to this technology due to its advantages of sensitivity, ease of use, dynamic range, and applicability to a wide range of analyses in the drug development process. In this article, we will examine the operation and use of CAD in a regulated environment, briefly address method development and validation specifics, and highlight a few examples illustrating some of its advantages when used in the pharmaceutical laboratory.