Chennai

18 March 2012

VALIDATED RP – HPLC METHOD FOR DETERMINATION OF MONTELUKAST SODIUM AND LEVOCETIRIZINE IN BULK AND ITS PHARMACEUTICAL FORMULATIONS USING UV-VIS DETECTOR

About Authors:
RAVISANKAR.M*¹, SUBASINI.U², ANAND THANGADHURAI.S³, KARTHIKEYAN.S⁴, CHANDRA SEKAR.E.⁵
^1.Swamy Vivekanandha College of pharmacy, dept of pharmaceutical analysis. Thiruchengode
^2.Swamy Vivekanandha College of pharmacy, dept of pharmacognosy. Thiruchengode
^3.Swamy Vivekanandha College of pharmacy, dept of pharmaceutical analysis. Thiruchengode
^4.Kausikh therapeutics and private limited.chennai
^5.Swamy Vivekanandha College of pharmacy, dept of pharmaceutical analysis. Thiruchengode

ABSTRACT
An isocratic reverse phase high performance liquid chromatographic method for estimation of montelukast sodium and levocetirizine in bulk dosage and in marketed formulations has been devised and validated. The chromatographic separation achieved on shodex c18-4E column (5µm, 250 mm x 4.6 mm) and acetonitrile: methanol: ammonium acetate buffer (PH- 5.5) in the ratio of 25:55:20 v/v. The flow rate was 1.0 ml/min and the UV detection was identified at 225nm.The retention times for montelukast sodium and levocetirizine was found to be 5.15 min and 3.12 min respectively. The linearity of montelukast sodium and levocetirizine is 10 -50µg/ml with the correlation co efficient 0.99 respectively. The validation parameters such as accuracy, precision, LOD, LOQ, Robustness, ruggedness were performed as per ICH guidelines. This method can be used for routine analysis of montelukast sodium and levocetirizine in bulk and marketed dosage forms.

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