Stability of meperidine in an implantable infusion pump using capillary gas chromatography-mass spectrometry and a deuterated internal standard.

摘要

A capillary gas chromatographic-mass spectrometric (GC MS) method is described for the analysis of meperidine using 3,3,5,5-[2H4]-meperidine as an internal standard. Chromatography was performed on a (5% phenyl) methylpolysiloxane column (30 m x 0.32 mm I.D., 0.25 microm film thickness) operated at 195 degrees C; helium carrier gas-50 cm/s(-1), tR = 2.3 min. Ionization was by electron impact (EI) and detection by selected ion monitoring of the molecular ions. The method provided high response linearity (mean r = 0.9982) and precision (< 6.5% C.V.). Application of this method to a pilot study of aqueous meperidine x HCl (10 mg/ml(-1)) stability in a surgically implantable infusion pump at 37 degrees C for 90 days revealed no demonstrable drug degradation.