Quantification of Lansoprazole in Oral Suspension by Ultra-High-Performance Liquid Chromatography Hybrid Ion-Trap Time-of-Flight Mass Spectrometry

Abstract EN

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 R2 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.