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Abstract

A RAPID, RP-UPLC ASSAY METHOD FOR SIMULTANEOUS DETERMINATION OF MONTELUKAST SODIUM AND LEVOCETIRIZINE DIHYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORMS

J. Bharati*, B. Chinnappa Naidu, M. Sumanth, Nagaraju Rajana

ABSTRACT

A stability indicating reversed phase ultra performance liquid chromatography (RP-UPLC) method was developed for simultaneous determination of Mountilicast sodium and Levocetrizine dihydrochloride in liquid pharmaceutical dosage forms. The desired chromato-graphic separation was achieved on an AQUITY BEH Phenyl 50mm x 2.1mm, 1.7μm column using gradient elution at 231 nm detector wavelength. The optimized mobile phase consists of 2.72 grams of Potassium dihydrogen phosphate to 1 L of Milli Q water. Mixed well and added 2ml of Triethyl amine and adjusted the pH of the solution to 6.5 using Ortho phosphoric acid. Filtered the solution through 0.22μ membrane filter and degas by sonication as a solvent-A and acetonitrile as a solvent-B. The developed method separates Mountilicast sodium and Levocetrizine dihydrochloride within 3.5 min. The developed RP-UPLC method was validated according to the International Conference on Harmonization (ICH) guidelines. This validated method is applied for simultaneous estimation of Mountilicast sodium and Levocetrizine dihydrochloride in various commercially available dosage forms.

Keywords: Montelukast sodium, Levocetirizine dihydrochloride, UPLC, Pharmaceutical dosage form.


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