A Novel validated stability indicating Chromatographic method for the Simultaneous estimation of Levocetrizine and Montelukast in the combined dosage form by RP-HPLC

The objective of the current study was to develop and validate a rapid, precise, specific reverse phase HPLC for the quantitative determination of Levocetrizine and Montelukast in its dosage form. The determination is done for the active pharmaceutical ingredient in its pharmaceutical dosage form. The dosage was subjected to analytical studies as per international conference on harmonization (ICH) prescribed. It was found Levocetrizine and Montelukast is very sensitive to different conditions. The chromatographic conditions were optimized using the samples. Regression analysis shows an r value (correlation coefficient) 0.998 and 0.999 respectively for Levocetrizine and Montelukast. The chromatographic separation was achieved on a Symmetry C18 (4.6 x 150mm, 3.5mm, Make: XTerra) or equivalent. The method employed an isocratic elution and the detection wave-length was set at 232 nm. The mobile phases consists of methnol : buffer (Ph 3.8) delivered at a flow rate of 1.0 mL/ min. The developed RP-LC method was validated with respect to linearity, accuracy, precision and robustness.