title: Comparison study of porous, fused-core, and monolithic silica-based C18 HPLC columns for Celestoderm-V Ointment analysis.
abstract: In this paper, three C18 columns with different substrates (i.e., porous ACE-3 C18, 3 microm, fused-core Halo C18, 2.7 microm, and monolithic Chromolith C18 were compared for the analysis of a pharmaceutical product, Celestoderm-V Ointment, that contains one active pharmaceutical ingredient, betamethasone-17-valerate and one critical pair of low level impurities, betamethasone-E-enolaldehyde and betamethasone-Z-enolaldehyde. Key column performance for the analysis of pharmaceutical products including selectivity, efficiency, separation impedance, resolution factor, sample loading capacity, linearity and lifetime from the three columns were determined. The potential applications of these three C18 columns for different methods for Celestoderm-V Ointment analysis are also recommended.
authors.affiliation: Global Quality Services-Analytical Sciences, Schering-Plough Corporation, Union, NJ 07083, USA.
authors.forename: Jinjian
authors.initials: J
authors.lastname: Zheng
authors.forename: Dolly
authors.initials: D
authors.lastname: Patel
authors.forename: Qinglin
authors.initials: Q
authors.lastname: Tang
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Markovich
authors.forename: Abu M
authors.initials: AM
authors.lastname: Rustum
mesh_terms: D001623:Betamethasone / Q000737:chemistry*; D001624:Betamethasone Valerate / Q000737:chemistry*; D002244:Carbon / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical / Q000379:methods; D002845:Chromatography / Q000379:methods; D002851:Chromatography, High Pressure Liquid / Q000295:instrumentation* / Q000379:methods*; D055664:Electrochemical Techniques; D008956:Models, Chemical; D009824:Ointments / Q000032:analysis*; D010316:Particle Size; D016062:Porosity; D015203:Reproducibility of Results; D012822:Silicon Dioxide / Q000737:chemistry*; D013499:Surface Properties; D013678:Technology, Pharmaceutical / Q000379:methods; D013997:Time Factors
chemical_list: D009824:Ointments; D002244:Carbon; D012822:Silicon Dioxide; D001623:Betamethasone; D001624:Betamethasone Valerate