title: Quantification of Lansoprazole in Oral Suspension by Ultra-High-Performance Liquid Chromatography Hybrid Ion-Trap Time-of-Flight Mass Spectrometry.
abstract: 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% (n = 5 for each concentration for each day) and 3.07 ± 0.89% (n = 20 for each concentration), respectively. Calibration curves (5-25 μg/mL) were found to be linear with an R(2) 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.
authors.affiliation: Department of Pharmaceutical Sciences, Bill Gatton College of Pharmacy East Tennessee State University, Box 70594, Johnson City, TN 37614, USA.
authors.forename: Stacy D
authors.initials: SD
authors.lastname: Brown
authors.forename: Justin D
authors.initials: JD
authors.lastname: Connor
authors.forename: Nicholas C
authors.initials: NC
authors.lastname: Smallwood
authors.forename: Ralph A
authors.initials: RA
authors.lastname: Lugo