Validation of a New RP-HPLC Method for Determination of Hydrocortisone Acetate Complexed with HPβCD in a Oral Liquid Pharmaceutical Preparation

Abstract

A simple reversed-phase high-performance liquid chromatographic method (RP-HPLC) for the simultaneous determination of hydrocortisone acetate (HA) complexed with 2-hydroxypropyl-β-cyclodextrin (HPβCD), its degradation products and preservative in an oral liquid pharmaceutical preparation has been validated. The compounds were separated on a 150mm x 4.6mm C 18 column packed with 5μm particles and a 1mm x 4mm pre-column with heating at 30 °C. The mobile phase optimized was a mixture of methanol, acetonitrile and water 35:25:40 (v/v/v), pumped at a flow rate of 1.0mL min-1 . The validation data showed that the proposed method is simple, reliable, fast and has good robustness, specificity, linearity, precision and accuracy.