RP-HPLC method for quantification of bilastine and monteleukast sodium in pharmaceutical dosage form

A simple, accurate, precise and robust reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous estimation of Bilastine and Monteleukast Sodium in bulk and pharmaceutical dosage form. Chromatographic separation was performed on an Zodiac sil RP C18 column (100mm × 4.6mm, 3μm) with mobile phase consist a mixture of 75:25% v/v acetonitrile: phosphate Buffer pH adjusted to 5.2 with ortho-phosphoric acid in an isocratic elution mode, at a flow rate of 1 ml/min. The detection was monitored at 272nm. The retention time of Monteleukast Sodium and Bilastine were found to be 3.668 min and 2.746 min respectively. Linearity range was found between 20-100μg/ml for Bilastine with correlation coefficient of 0.999 and 5-25μg/ml for Monteleukast Sodium with correlation coefficient of 0.999. This method was validated with respect to linearity, precision, accuracy, ruggedness, limit of detection, limit of quantification and robustness. This method was successfully applied for the simultaneous estimation of Bilastine and Monteleukast Sodium in bulk and pharmaceutical formulation.