Optimization and validation of a dissolution test for selegiline hydrochloride tablets by a novel rapid HPLC assay using a monolithic stationary phase.

Abstract:

: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).

journal_name

J Pharm Biomed Anal

authors

Tzanavaras PD,Themelis DG,Zotou A,Stratis J,Karlberg B

doi

10.1016/j.jpba.2007.11.039

subject

Has Abstract

pub_date

2008-03-13 00:00:00

pages

670-5

issue

4

eissn

0731-7085

issn

1873-264X

pii

S0731-7085(07)00691-7

journal_volume

46

pub_type

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