Development and validation of RP-HPLC method for simultaneous determination of montelukast sodium and levocetirizine dihydrochloride tablets

A simple, sensitive and accurate isocratic reverse phase high performance liquid chromatography method was developed for simultaneous determination of montelukast sodium and levocetirizine dihydrochloride in tablets. The effective separation was achieved on Hypersil C18, 100 x 4.6 mm, 3 µm. The mixture of buffer and acetonitrie in the ratio 90: 10v/v used as a mobile phase. The buffer was prepared as 2.8g of disodium hydrogen orthophosphate in 1000 ml of purified water and adjusts the pH 7.0 with diluted orthophosphoric acid. The flow rate of the mobile phase was 1.0mL/min and the total elution time was 15 minutes. The UV detection wavelength was carried at 230 nm and experiments were conducted at 25°C. The developed method was validated in terms of system suitability, selectivity, linearity, precision, accuracy, limits of detection and quantification for the impurities following the ICH guidelines.

Author(s): N. Jayasimha, V. Krishna Reddy and E. Sasi Kiran Goud

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