Systematic Troubleshooting for LC/MS/MS

www.pharmtech.com evelopment and validation of bioanalytical methods for pharmaceutical product analysis are common rate-limiting steps in biopharmaceutical product development. A rational, strategic approach to developing robust, automated, validated bioanalytical methods can reduce slowdowns and bottlenecks in drug development and contribute to synergistic, consistent, longterm performance. The use of liquid chromatography with tandem mass spectrometry detection (LC/ MS/MS) for bioanalysis has grown exponentially in the pharmaceutical industry since the 1980s. The popularity of this method is attributed to its superior sensitivity, extraordinary selectivity, and rapid rate of analysis. Adoption of LC/MS/MS has been driven by the need for timely, high-quality data at various stages of the drug development process — from highthroughput screening of drug candidates and prompt data generation for preclinical studies to almost real-time analysis of clinical samples (1). Rapid and rational LC/MS/MS methods play an important role in bioanalytical sample analysis and shortening cycle times for biopharmaceutical product development (2).