A NOVEL METHOD DEVELOPMENT AND VALIDATION OF PANTOPRAZOLE IN PURE AND CAPSULE DOSAGE FORMS BY USING UV- SPECTROPHOTOMETRIC METHOD

Suresha D. N.*, Akza T. Moncy, Anagha Vinod, Lukman, Sachith M. P. and Shebin John

ABSTRACT

A Novel, simple, accurate, and precise Area under curve spectroscopic method was developed and validated for the estimation of Pantoprazole in Pure and Capsule dosage forms and has an absorption maximum between 288-298nm in 0.1N Sodium hydroxide. The stock solution was made to produce 1000 μg/ml with 0.1N Sodium hydroxide. The linearity was found in the concentration range of 3-18 μg/ml. The correlation coefficient was found to be 0.9999. The regression equation was found to be Y=0.031x+0.0025. The method was validated for linearity, accuracy, precision, limit of detection, limit of quantitation and ruggedness. The limit of detection and limit of quantitation for estimation of Pantoprazole was found to be 0.03632μg/ml and 0.3632μg/ml, respectively. Recovery of Pantoprazole was found to be in the range of 99.29% - 99.92%. The %RSD values were less than 2. The method has been validated according to ICH guidelines. The Proposed method was successfully applied for the quantitative determination of Pantoprazole in Capsule dosage forms.

Keywords: Pantoprazole, Area under Curve Spectroscopy, 0.1N Sodium hydroxide, accuracy.