SIM-6080

A sensitive and selective gas chromatographic/mass spectrometric assay for the determination of the calcium antagonist SIM6080 in plasma was developed and validated. SIM6080 was extracted from plasma by a three‐step solvent extraction procedure and separated by capillary gas chromatography combined with mass spectrometric detection. Chemical ionization using ammonia as the reagent gas was used and the protonated molecular ion was monitored. The defluorinated analogue was used as an internal standard. The analysis of spiked plasma demonstrated good accuracy and precision of the assay with a quantitation limit of 0.5 ng ml−1 and a detection limit of 0.1 ng ml−1. The method was used for phase I pharmacokinetic studies.

A sensitive and selective gas chromatographic method for the determination of the calcium antagonist SIM6080 in plasma has been developed and validated. A three-step extraction procedure is employed followed by capillary gas chromatographic analysis using nitrogen-selective detection and the programmed temperature vaporizer injection technique. The defluorinated analogue was used as the internal standard. The analysis of spiked plasma demonstrated the good accuracy and precision of the method with limit of detection of 1 ng/ml. The method has been used for pharmacokinetic studies in laboratory animals.