Simultaneous Estimation of Montelukast Sodium and Levocetrizine Hydrochloride by RP-HPLC Method

The present paper deals with the development of RP-HPLC method for the determination of montelukast sodium and levocetrizin hydrochloride in bulk and in formulation using UV detector. Selected mobile phase was a combination of acetonitril, methonal, and water (40:40:20) and the wavelength selected was 232 nm. The flow rate was kept at 1 ml/min, and the injection volume was 20 μl. The separation was performed at ambient temperature. Retention time of montelukast sodium was 11.81 min and for levocetrizine hydrochloride was 6.01 min. Linearity of the method was found to be 0.030 to 0.060 mg/ml for montelukast sodium and 0.030 to 0.060 mg/ml for levocetrizine hydrochloride with the regression coefficient of 0.991 and 0.994 for montelukast sodium and levocetrizine hydrochloride respectively. This method was validated according to ICH guidelines.