Analytical method development and validation for simultaneous estimation of naproxen and pantoprazole in capsule dosage form by RP-HPLC

Abstract

A simple, rapid, precise, accurate RP-HPLC method has been developed and validated for the simultaneous estimation of
Naproxen and Pantoprazole in combined dosage forms. Chromatographic separation was achieved with mobile phase
consisting of Methanol: Phosphate Buffer PH
5.4in the ratio of 70:30 v/v with Hypercil C18 (250 × 4.6 mm × 5
μm),column at a flow rate of 1 mL/minand detection wavelength was 259 nm. The retention times of Naproxen and
Pantoprazole was found to be 3.33 minand 1.90 minrespectively. The method was validated in terms of Linearity, Range,
Accuracy, Precision, Specificity, LOD, LOQ, Robustness and system suitability according to ICH guidelines. Commercial
Capsule formulation was successfully analyzed using the developed method and the proposed method is applicable to
routine analysis for determination of Naproxen and Pantoprazole in Capsule dosage form.