A Sensitive, Validated Gas‐chromatographic Bioanalytical Method by Nitrogen Selective Detection of Deramciclane in Dog Plasma

Abstract

A validated bioanalytical method has been developed for the determination of a new anxiolytic compound of deramciclane in dog plasma, using Lichrolut RP-18 solid-phase extraction and gas chromatography with nitrogen-phosphorous selective detector (GC-NPD). Gas-chromatographic separation was carried out by SPB-5 fused silica capillary column (30 m × 0·25 mm × 0·25 μm) after split injection, when the split liner was packed (3% silicone SE 30). An optimized two-level oven temperature program was used for the separation. The assay was validated with respect to selectivity, specificity, linearity, sensitivity, accuracy, precision, system suitability and plasma stability. All validation parameters were found to be within the internationally required limits. The limit of quantification of deramciclane in dog plasma was found to be 0·5 ng mL−1. The calibration curve showed good linearity (r=0·999) over the 0·5 and 100 ng mL−1 deramciclane plasma concentration range. The assay is sufficiently sensitive and relatively fast (12·5 min chromatographic run) to be used for routine monitoring and pharmacokinetic studies of deramciclane.