Optimization and validation of a dissolution test for selegiline hydrochloride tablets by a novel rapid HPLC assay using a monolithic stationary phase.
The present study reports the optimization and validation of a dissolution test for selegiline.HCl tablets using a new high-performance liquid chromatographic (HPLC) method. Rapid separation of the analyte from sample matrix was achieved in less than 60s using a Cromolith RP-18e monolithic column using UV detection at 220 nm. Thorough validation of the assay based on pre-defined criteria included linearity, LOD/LOQ, accuracy, precision, selectivity and ruggedness. The dissolution test was optimized in terms of dissolution medium, basket (type I)/paddle (type II) agitation and rotation speed. Its ruggedness was also validated. The presented analytical and dissolution procedures are currently being applied in the quality and stability control of Cosmopril tablets (5mg/tablet selegiline.HCl, Cosmopharm Ltd., Korinthos, Greece).
Tzanavaras
Paraskevas D
PD
Laboratory of Analytical Chemistry, Department of Chemistry, Aristotle University of Thessaloniki, GR-54124 Thessaloniki, Greece. ptzanava@chem.auth.gr
Themelis
Demetrius G
DG
Zotou
Anastasia
A
Stratis
John
J
Karlberg
Bo
B
D015203:Reproducibility of Results; D012642:Selegiline / Q000032:analysis / Q000737:chemistry*; D012995:Solubility; D013607:Tablets
D013607:Tablets; D012642:Selegiline