Abstract
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ESOMEPRAZOLE IN BULK AND TABLET DOSAGE FORM BY RP-HPLC

Saurabh P. Andhale (M,Pharm)* and Dr. R.B. Saudagar (M,Pharm, PhD)

ABSTRACT

A simple, rapid, accurate, precise and reproducible Reverse Phase HPLC method was developed for the quantitative estimation of Esomeprazole in bulk and tablet dosage form. Esomeprazole is used as antiulcerative. The chromatographic separation was achieved with 250 x 4.6 mm, i.d. 5 μm C-18 column using methanol: water (80:20 v/v) at the flow rate of 0.8 ml/min at 302 nm. The linearity range was found to be 20-60 μg/ml for Esomeprazole. The coefficient of correlation for Esomeprazole was found to be 0.9962. The percent recovery obtained for Esomeprazole was found to be 98.64% the method was validated for linearity, range, precision, accuracy, specificity, selectivity, intermediate precision, ruggedness, robustness, stability and suitability.

Keywords: coefficient of correlation, Esomeprazole, intermediate precision.


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