Development and Validation by RP-HPLC Method for the Simultaneous Quantification of Diclofenac and Rabeprazole, in Capsule Formulation

Abstract

Objective: Determination of Diclofenac and Rabeprazole in capsules formulations using reverse phase high pressure liquid chromatography method. Method/Statistical Analysis: Chromatographic separation was carried out on a Thermo hypersil-keystone C18 (250 x 4.6 mm, 0.5 μ) column in isocratic mode, using a mobile phase mixture comprising a 20:50:30 (% v/v/v) of Acetonitrile: methanol: phosphate buffer and UV detection at 257 nm. The percentage recoveries 100.11% and 110.04% respectively. The amount of Diclofenac and Rabeprazole found per capsule was 100.08 mg and 20.03 mg respectively. Findings: The proposed reverse phase high pressure liquid chromatography method shows good separation of Diclofenac sodium and Rabeprazole, were retention time was found to 5.3 (±0.5) min for Diclofenac sodium and 3.5 (±0.5) min for Rabeprazole, which show very less time consuming analysis. No previous method of analysis shows good separation at less retention time and less cost. Linearity range for Diclofenac and Rabeprazole were 25-125 μg/ml, 5-25 μg/ml. Application: The developed method can be successfully applied for estimation and determination of Diclofenac and Rabeprazole in bulk powder and combined capsule form.