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Application of LC-MS/MS for the Analysis of Biomolecular Drugs and Biomarkers in Pharmaceutical Development

Mass spectrometry has developed rapidly to become an important analytical technique. However, application to the analysis of biological specimens was at first limited because the ionization processes could only be applied to compounds of low molecular weight, and the instrument interfaces did not permit easy introduction of biological samples into the mass spectrometer. This changed dramatically in the 1980s when electrospray ionization was introduced, enabling the ionization of larger bio-molecules, as well as straightforward coupling of the mass spectrometer (MS) to liquid chromatography (LC). The use of a tandem mass spectrometer (MS/MS) provided additional specificity and sensitivity and LC-MS/MS has become the mainstay analytical technique in pharmaceutical research.

LC-MS/MS is now used for the quantification of large and small molecule drugs, or biomarkers in biological fluids. The advantages it has over other techniques include high sensitivity and excellent specificity compared to conventional LC detectors or immunoassays, allowing routine analysis at nanogram to picogram levels, over a wide dynamic range in a much shorter time frame.

Bioanalytical Techniques

In the field of bioanalysis, LC-MS/MS is the preferred analytical technique, combined with techniques such as GC-MS/MS and ICP/MS almost all chemical compounds can be quantified. 

LC-MS/MS is used for bioanalysis at all stages of drug development (discovery, preclinical and clinical phases I to IV). Service providers use the technique to provide high-quality data, within tight timelines, that meet the stringent demands of the regulatory authorities. The high performance characteristics of LC-MS/ MS allow high throughput of samples and generate data that is precise and accurate. 

At Impact Analytical we have installed 2 of the latest edition Shimadzu LC-MS/MS (8060NX Triple Quadrupole Mass Spectrometers). This latest generation hardware, with ion focusing technology, allows us to reach previously un-obtainable detection limits.

For more information on our BioAnalytical Services, please click here.

Shimadzu LC-MS/MS (8060NX Triple Quadrupole Mass Spectrometers)

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