Abstract
RP-HPLC ESTIMATION OF MONTELUKAST SODIUM AND OLOPATADINE HYDRO CHLORIDE IN PHARMACEUTICAL TABLET DOSAGE FORM

Alagar Raja.M*, Saikumar. CH. Rao.KNV, DavidBanji, SelvaKumar.D

ABSTRACT

A simple, economic, accurate and precise HPLC method was successfully developed. In simultaneous RP-HPLC method development, the estimation was carried out by using the Hypersil C18 column (4.6 X 150 mm) with 5μm particle size. Injection volume of 20μl is injected and eluted with the mobile phase Acetonitrile: 0.02M potassium dihydrogen phosphate 0.1% triethylamine) in the ratio of 60: 40 and the buffer pH is maintained at 5.0 and adjusted with 0.01M Phosphoric acid, which is pumped at a flow rate of 1.0 ml/min. Detection was carried out at 270 nm. The peaks obtained were sharp with retention time of 3.133 min Olopatadine Hydro Chloride for 5.137min for Montelukast Sodium. The peaks were well resolved with a resolution factor of 5.03. The method was precisely applied to the tablet formulation and the results obtained were accurate and reproducible. System suitability studies were also carried out which includes theoretical plates, resolution factor and tailing factor etc. And validation study compared as per ICH guideline.

Keywords: HPLC, Montelukast sodium, Olopatadine Hydro Chloride.


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