Validated RP-HPLC Method for Simultaneous Quantitation of Domperidone Maleate and Naproxen Sodium in Bulk Drug and Formulation 

By Shubhangi M. Pawar, Jitendra D. Fegade and Rajesh Y. Chaudhari 

ABSTRACT

This paper describes a new, simple, precise, and accurate HPLC method for simultaneous quantitation of Domperidone Maleate (DOM) and Naproxen Sodium (NAP) as the bulk drug and in tablet dosage form. Chromatographic separation of the drugs was achieved on a Eurosphere C18 column (5 µm, 250 mm × 4.6 mm, i.d.) with the isocratic mobile phase methanol: sodium acetate buffer (60:40 v/v, pH 3.6 adjusted with acetic acid) at a flow rate of 1 mL/min. The UV detection wavelength was 266 nm. The two drugs were satisfactorily resolved with retention times 3.21 min and 7.45 min for DOM and NAP, respectively. Linearity was found to be in the range of 10-60 µg/mL for DOM and 25-150 µg/mL for NAP with significantly high value of correlation coefficient (0.9974 for DOM and 0.9992 for NAP). The percentage recovery obtained was 98.86 % for DOM and 99.55 % for NAP. 

Keywords: RP-HPLC, Domperidone Maleate, Naproxen Sodium, Method validation

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