Evaluation of monolithic HPLC columns for various pharmaceutical separations: method transfer from conventional phases and batch to batch repeatability

J Pharm Biomed Anal. 2007 May 9;44(1):85-95. doi: 10.1016/j.jpba.2007.01.045. Epub 2007 Feb 3.

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.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Adrenergic beta-Antagonists / analysis
  • Buffers
  • Chromatography, High Pressure Liquid / instrumentation*
  • Chromatography, High Pressure Liquid / methods
  • Excipients
  • Glyburide / analysis
  • Glyburide / chemistry
  • Hydrogen-Ion Concentration
  • Hypoglycemic Agents / analysis
  • Insulin / analysis
  • Insulin / chemistry
  • Ophthalmic Solutions / analysis
  • Pharmaceutical Preparations / analysis*
  • Pilocarpine / analogs & derivatives
  • Pilocarpine / analysis
  • Pilocarpine / chemistry
  • Propranolol / analysis
  • Propranolol / chemistry
  • Reference Standards
  • Reproducibility of Results
  • Solvents / chemistry
  • Sulfonylurea Compounds / analysis
  • Sulfonylurea Compounds / chemistry
  • Time Factors

Substances

  • Adrenergic beta-Antagonists
  • Buffers
  • Excipients
  • Hypoglycemic Agents
  • Insulin
  • Ophthalmic Solutions
  • Pharmaceutical Preparations
  • Solvents
  • Sulfonylurea Compounds
  • Pilocarpine
  • glimepiride
  • Propranolol
  • Glyburide