A simple and cost-effective synthesis of sulfated β-cyclodextrin and its application as chiral mobile phase additive in the separation of cloperastine enantiomers

A simple and cost-effective method for the synthesis of sulfated β-cyclodextrin, one most widely used chiral mobile phase additives, using sulfamic acid as a sulfonating agent has been described. The was optimized, synthesized product characterized by spectroscopic, size-exclusion chromatographic, thermal, microscopic methods compared to marketed Sigma Aldrich β-cyclodextrin. β-Cyclodextrin, hydroxypropyl β-cyclodextrin (marketed synthesized) were evaluated additives enantiomeric separation cloperastine, an antitussive agent, reversed-phase HPLC. Under optimized conditions, resolution 3.14 achieved within 15 min on achiral Kromasil C8 (150 × 4.6 mm, 5 µm) column, with mM monopotassium phosphate containing 10 pH 3.0 45% methanol phase. utilizing additive validated per ICH guidelines applied quantitative determination cloperastine enantiomers in active pharmaceutical ingredients formulations. selectivity changes imparted proven be beneficial separation. For afforded better than