Development and validation of a highly sensitive gradient chiral separation of pramipexole in human plasma by LC-MS/MS

Bioanalysis
Marco MichiLara Solazzo

Abstract

Development of a high-sensitivity chiral LC-MS/MS method was required to evaluate a combination of pramipexole (S-PPX) and its enantiomer dexpramipexole (R-PPX) in a proposed clinical trial. The previously available methods suffered from low sensitivity for the (S)-enantiomer in the presence of the more abundant (R)-enantiomer. Based on the projected dosing regimen in the clinical trial, a 5000-fold improvement in sensitivity was required for the (S)-enantiomer. Spiked human plasma samples were extracted by liquid-liquid extraction using ethyl acetate and injected onto a CHIRALPAK ID column under pH gradient conditions. An improved analytical method was developed and validated with a final LLQ for (S)-PPX of 0.1 ng/ml in the presence of 2000 ng/ml of (R)-PPX.

References

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Oct 8, 2014·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Dong WeiLiyu Yang

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Citations

Jan 22, 2021·Journal of Chromatography. a·Abhijit Tarafder, Larry Miller

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