DEVELOPMENT AND VALIDATION OF FAST REVERSED-PHASE HPLC METHOD FOR ANALYSIS OF ESOMEPRAZOLE IN RABBIT PLASMA.
Journal:
Acta poloniae pharmaceutica
PMID:
29624243
Abstract
The present study focused to develop rapid, accurate and sensitive reversed-phase high pressure liquid chromatography method for the quantification of esomeprazole (ESO) magnesium in rabbit plasma. Chromatographic separation was achieved isocratically on a reversed-phase C,, column using simple mobile phase consisting of of methanol : acetonitrile: 0.05 M phosphate buffer, pH 7 adjusted with potassium hydroxide (45 : 10 : 45, v/v/v) at a flow rate of 1.0 mL/min and UV detection at 302 nm. The method was validated for system suitability, linearity, precision, accuracy, stability, robustness, LOD and LOQ. The described method stated good linearity over the range of 0.01 to 2.5 pg/mL (r = 0.999). The extraction recovery of esomeprazole was more than 95.3%. The method was precise with relative standard deviation < 1% with more than 90% accuracy and limit of quantification 0.0309 μg/mL. The freeze thaw stability studies indicated that the rabbit plasma samples containing esomeprazole could be stored in freezer at -20⁰C and handled under normal laboratory conditions without significant loss of drug. In conclusion, the developed method is simple, cost effective and reproducible, with improved sensitivity and running time of analysis.
Authors
Keywords
Acetonitriles
Animals
Buffers
Chromatography, High Pressure Liquid
Chromatography, Reverse-Phase
Cold Temperature
Drug Monitoring
Drug Stability
Esomeprazole
Freezing
Hydrogen-Ion Concentration
Hydroxides
Limit of Detection
Linear Models
Methanol
Potassium Compounds
Proton Pump Inhibitors
Rabbits
Reproducibility of Results
Solvents
Spectrophotometry, Ultraviolet