Quality control of pentosane polysulfate by capillary zone electrophoresis using indirect detection

Pentosane polysulfate sodium salt (PPS) is a mixture of multiply charged anionic polysaccharides, used for urological treatment. Several constituents of the polysaccharide can be characterized by a highly reproducible fingerprint. In comparison with earlier approaches the separation efficiency has been further improved using an anionic benzene-1,2,4-tricarboxylic acid buffer (8.7 mmol l(-1), pH=4.9) with indirect UV detection (lambda=217 nm) and a special capillary pretreatment (1 M NaOH for 10 h at 25 degrees C applying -20 kV). The method has been optimized with regard to buffer concentration and pH. The robustness was tested on several capillaries. PPS was separated from all major synthetic impurities such as sulfate, chloride and acetate. Twelve PPS batches from two manufacturers were measured and compared. (C) 1998 Elsevier Science B.V. All rights reserved.