DEVELOPMENT OF AN HPLC METHOD FOR THE ANALYSIS OF 1-METHYL-4-PHENYL-1,2,3,6-TETRAHYDROPYRIDINE IN A POTENTIAL ANTIPSYCHOTICACTIVE PHARMACEUTICAL INGREDIENT

Abstract

An HPLC assay was developed which could detect 2 ppm of MPTP (1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine) in CI-1007 maleate bulk pharmaceutical chemical. The method is an ion-pairing HPLC assay which uses a mobile phase containing sodium dodecyl sulfate (SDS) (600 0.083M SDS at pH4: 400 Acetonitrile) and a C₈ column (Waters Symmetry C₈, 250 × 4.6 mm) to selectively separate MPTP, a neurotoxin that destroys brain dopamine neurons and produces Parkinson-like symptoms when administered intravenously, and HPTP (4-phenyl-1,2,3,6-tetrahydropyridine) from CI-1007 and maleic acid. This method exhibited improved system precision, linearity, limit of quantitation, and accuracy, in comparison to a previously developed HPLC method that used an ammonium acetate buffered mobile phase.

ACKNOWLEDGMENTS

We would like to thank Dr. Charles Kulier for assistance with the references, and Dr. Donald Butler for informative discussions.