HPLC Determination of Esomeprazole Magnesium in Tablets

Abstract

A simple, rapid and precise HPLC method was developed and validated in the determination of esomeprazole magnesium in tablets. The method employed the Phenomenex Luna C₁₈ column with a mobile phase of ammonium dihydrogen phosphate buffer and methanol at a flow rate of 0.8 mL/min and UV detection at 302 nm. Validation parameters, such as linearity, limit of detection (LOD), limit of quantification (LOQ), selectivity, precision, accuracy and robustness were determined. A linear response (r² > 0.999) was observed in the range of 10-400 μg/mL equivalent to esomeprazole magnesium. The method shows good recoveries, repeatability and intermediate precision. Relative standard deviations of all these three parameters were less than 1.1 %. Finally, the established HPLC method was successfully applied for the quantitative determination of esomeprazole magnesium in tablets.