N,N'-Ethylenebisstearamide Additive in Intravaginal Drug Delivery Device Determined by NP-LC with ELSD

摘要

A new method for N,N'-ethylenebisstearamide analysis was developed and validated in NP-LC with evaporative light scattering detection for EBS content in drug delivery device. Chromatographic conditions were silica column 250 x 3 mm at 45 A degrees C with 94:6 CHCl3/ethanol at 0.5 mL min(-1). The retention time of N,N'-ethylenebisstearamide was 4.35 min. The method was fully validated by applying a novel strategy using accuracy profiles. The EBS content in the progesterone device was established after administration in animal which proved that such additives did not migrate into the animal.