DETERMINATION OF ESOMEPRAZOLE IN PHARMACEUTICAL DOSAGE FORM USING UV AND RP HPLC METHOD

Abstract

This study presents the development and validation of analytical methods for the quantitative estimation of Esomeprazole, the S-enantiomer of omeprazole and a potent proton pump inhibitor (PPI) widely used in the management of acid-related gastrointestinal disorders including GERD, peptic ulcer disease, and Zollinger–Ellison syndrome. Two complementary analytical techniques – UV spectrophotometry and RP-HPLC – were developed and validated in accordance with ICH guidelines. The UV method involved measuring the absorbance of Esomeprazole at 305 nm using methanol as solvent. The method demonstrated excellent linearity within the concentration range of 2–12 µg/mL, with a correlation coefficient (r²) of 0.9961. The RP-HPLC method was optimized using a mobile phase of 0.1% Triethylamine: Methanol (70:30, v/v), with detection at 250 nm on a C18 column (250 × 4.6 mm, 5 µm) at a flow rate of 1.0 mL/min, yielding a retention time of approximately 4.13 minutes. The HPLC method demonstrated linearity over the concentration range of 32–48 µg/mL (80–120%), with a correlation coefficient (r²) of 0.9998. Validation parameters including precision, accuracy, LOD, LOQ, specificity, repeatability, and robustness confirmed the suitability of both methods. Both analytical methods were found to be simple, precise, accurate, economical, and reproducible, confirming their applicability for routine quality control of Esomeprazole in pharmaceutical dosage forms.