Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS UV SPECTROPHOTOMETRIC ESTIMATION OF DEXLANSOPRAZOLE AND DOMPERIDONE

Kumara Prasad S. A.*, Abhiram M. S. and Raju H. V.

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Abstract

In the present study, a simple and sensitive UV spectrophotometric absorbance ratio method was developed for the simultaneous estimation of Dexlansoprazole and Domperidone in bulk and pharmaceutical formulations. The absorbance ratio method is based on the measurement of absorbance at two selected wavelengths: one at the isoabsorptive point (279 nm) and the other at the λmax of Domperidone (285 nm). The method was successfully applied to the analysis of Dexlansoprazole and Domperidone in a sample formulation, yielding 55.67 mg of Dexlansoprazole and 28.69 mg of Domperidone, which complies with the labeled claim of 60 mg and 30 mg, respectively. The method obeyed Beer’s law in the concentration range of 10–50 μg/ml for Dexlansoprazole and 5–25 μg/ml for Domperidone. The calibration curves exhibited good linearity, with correlation coefficients (r²) of 0.999 for Dexlansoprazole and 0.998 for Domperidone. The limit of detection (LOD) was determined to be 0.4 μg/ml for Dexlansoprazole and 0.2 μg/ml for Domperidone. The developed method is accurate, precise, and reproducible, making it suitable for routine quality control analysis of Dexlansoprazole and Domperidone in pharmaceutical dosage forms.

Keywords: Dexlansoprazole, Domperidone, Absorbance ratio.