title: Evaluation of monolithic HPLC columns for various pharmaceutical separations: method transfer from conventional phases and batch to batch repeatability.
abstract: Methods developed on conventional particle-packed C18 columns for pilocarpine, propranolol, glibenclamide, glimepiride, insulin and their respective degradation products or related compounds were transferred from the conventional Superspher 100RP-18e column to Chromolith Performance RP-18e columns. All transfers were successful applying the same chromatographic conditions, except for insulin where the acetonitrile content of the mobile phase was reduced by 0.5%. The intraday and interday precisions for both retention time and peak area were evaluated over a wide concentration range. Results were found to be equal, or slightly better on Chromolith Performance with RSD%<1.1% in all cases. Monolithic batch to batch repeatability of both retention time and peak area, compared for monolithic columns from different batches gave an RSD% of less than 1.3%. The separation of each drug and its related products was investigated on monolithic columns at flow rates from 1 to 9 ml/min, and superior resolution was always obtained using monolithic over conventional columns at the same flow rate. A total of seven monolithic columns from four different batches were used in this study.
authors.affiliation: Institute of Pharmaceutical Chemistry, Technical University Braunschweig, Beethovenstrasse 55, D-38106 Braunschweig, Germany.
authors.forename: S
authors.initials: S
authors.lastname: El Deeb
authors.forename: L
authors.initials: L
authors.lastname: Preu
authors.forename: H
authors.initials: H
authors.lastname: Wätzig
mesh_terms: D000319:Adrenergic beta-Antagonists / Q000032:analysis; D002021:Buffers; D002851:Chromatography, High Pressure Liquid / Q000295:instrumentation* / Q000379:methods; D005079:Excipients; D005905:Glyburide / Q000032:analysis / Q000737:chemistry; D006863:Hydrogen-Ion Concentration; D007004:Hypoglycemic Agents / Q000032:analysis; D007328:Insulin / Q000032:analysis / Q000737:chemistry; D009883:Ophthalmic Solutions / Q000032:analysis; D004364:Pharmaceutical Preparations / Q000032:analysis*; D010862:Pilocarpine / Q000031:analogs & derivatives / Q000032:analysis / Q000737:chemistry; D011433:Propranolol / Q000032:analysis / Q000737:chemistry; D012015:Reference Standards; D015203:Reproducibility of Results; D012997:Solvents / Q000737:chemistry; D013453:Sulfonylurea Compounds / Q000032:analysis / Q000737:chemistry; D013997:Time Factors
chemical_list: D000319:Adrenergic beta-Antagonists; D002021:Buffers; D005079:Excipients; D007004:Hypoglycemic Agents; D007328:Insulin; D009883:Ophthalmic Solutions; D004364:Pharmaceutical Preparations; D012997:Solvents; D013453:Sulfonylurea Compounds; D010862:Pilocarpine; C057619:glimepiride; D011433:Propranolol; D005905:Glyburide