An LC-MS/MS method was developed and validated to be used as a stability indicating assay for the study of a 3 mg/mL lansoprazole oral suspension. The method utilizes a UPLC (ultra-performance liquid chromatography) column and unique mass spectrometric detection (ion-trap time-of-flight (IT-TOF)) to achieve a sensitive (LOD 2 ng/mL), accurate, and reproducible quantification of lansoprazole. This method reports an intraday and interday coefficient of variation of 2.98 ± 2.17% ( for each concentration for each day) and 3.07 ± 0.89% ( for each concentration), respectively. Calibration curves (5–25 μg/mL) were found to be linear with an value ranging from 0.9972 to 0.9991 on 4 different days. Accuracy of the assay, expressed as % error, ranged from 0.30 to 5.22%. This method is useful for monitoring the stability of lansoprazole in oral suspension.
Available at: http://works.bepress.com/stacy-brown/76/
Copyright © 2011 Stacy D. Brown et al. This document was originally published in the International Journal of Analytical Chemistry.