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 Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
Tzanavaras PD,Themelis DG,Zotou A,Stratis J,Karlberg Bdoi
10.1016/j.jpba.2007.11.039subject
Has Abstractpub_date
2008-03-13 00:00:00pages
670-5issue
4eissn
0731-7085issn
1873-264Xpii
S0731-7085(07)00691-7journal_volume
46pub_type
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journal_title：Journal of pharmaceutical and biomedical analysis
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journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章,评审
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journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章,评审
doi：10.1016/j.jpba.2006.02.052
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journal_title：Journal of pharmaceutical and biomedical analysis
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journal_title：Journal of pharmaceutical and biomedical analysis
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