Abstract

A NOVEL RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF DEXLANSOPRAZOLE IN BULK AND EXTENDED-RELEASE CAPSULES

Lakshmi Keerthi B.*, Deepthi R., Dr. Srinivasa Rao Y. and VaraprasadaRao K.

Abstract

A simple, precise, specific, and accurate RP-HPLC method has been developed and validated for the estimation of Dexlansoprazole in bulk and capsule dosage formulation. The separation was achieved by Enable C18column (250X 4.6mm, 5μm particle size) using a mobile phase consisting of methanol and water (95:5, v/v) at a flow rate of 1mL / min using detection wavelength at 247nm. The method was developed in isocratic mode. The retention time was around 2.914mins. The method showed linearity with correlation coefficient R2=0.997 over the range of 20-120μg/mL. The mean recoveries were found to be in the range of 99.3-99.7% for Dexlansoprazole. The method was validated as per ICH guidelines for linearity, the limit of Detection, the limit of quantification, accuracy, precision, and robustness, ruggedness. The method can be successfully applied for routine analysis of the quantitative determination of Dexlansoprazole in the pharmaceutical dosage form.

Keywords: Dexlansoprazole, RP-HPLC, Method development, validation, ICH.