Research Article | Volume: 2 Issue: 8, August 2012

A Validated Comparitative LC and Ratio First Derivative Spectrophotometric Method for the Simultaneous Determination of Levocetrizine dihydrochloride and Montelukast sodium in Bulk and Pharmaceutical dosage forms

R. Swethan Babu K. Anirudha Bharadwaj N.C Arjun Nagaraj Venkatesh Prasad   

Open Access    DOI: 10.7324/JAPS.2012.2842

Abstract

A new simple, rapid, precise reverse phase-high performance liquid chromatographic (RP-HPLC) and ratio spectra first derivative spectroscopy (1DD) methods has been developed for the simultaneous determination of Levocetrizine dihydrochloride (Levo) and Montelukast sodium (Mont) in bulk active pharmaceutical ingredient (API) as well as in tablet dosage form. In RP-HPLC method, separation was performed using phenomex-luna 5µ C8 (2) (100Å, 250 X 4.6 mm) column by using acetonitrile: 0.5% triethylamine in water (90:10 v/v) pH adjusted to 5.5 ± 0.1 with orthophosphoric acid. The flow rate was 0.8 ml/min with UV detection monitored at 231 nm. The retention time was 3.8 and 5.2 min for Levo and Mont respectively. In ratio spectra first derivative method, linearity range was found to be 2-32 µg/mL and 3-30 µg/mL for Levo and Mont respectively. From the first derivative (1DD) suitable wavelength was selected and amplitudes were measured at 240 nm and 281 nm for the assay of Levo and Mont by considering concentration of 18 µg/mL of Mont and 24 µg/mL of Levo as a suitable divisor, respectively. The validation of method was carried out according to ICH guidelines.


Keyword:     HPLC Ratio spectra first derivative Levocetrizine dihydrochloride Montelukast sodium.


Copyright:The Author(s). This is an open access article distributed under the Creative Commons Attribution Non-Commercial License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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