A STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTAENOUS ESTIMATION OF MONTELUKAST AND FEXOFENADINE HYDROCHLORIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM

A new method was established for simultaneous estimation of Fexofenadine Hcl and Montelukast by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Fexofenadine Hcl and Montelukast by using Xterra C18 5 mu m (4.6*250mm) column, flow rate was 1ml/min, mobile phase ratio was Phosphate buffer (0.05M) pH 4.6: ACN (55:45% v/v) (pH was adjusted with orthophosphoric acid), detection wave length was 255nm. The instrument used was Shimadzu, model No. SPD-20MA LC+20AD, Software-LC-20 Solution. The retention times were found to be 2.399mins and 3.907mins. The % purity of Fexofenadine Hcl and Montelukast was found to be 100.7% and 101.4% respectively. The system suitability parameters for Fexofenadine Hcl and Montelukast such as theoretical plates and tailing factor were found to be 1.3, 5117.5and 1.4, 3877.3 the resolution was found to be 8.0. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study for Fexofenadine Hcl and Montelukast was found in concentration range of 1 mu g-5 mu g and 100 mu g-500 mu g and correlation coefficient (r2) was found to be 0.999 and 0.999, % mean recovery was found to be 100% and 100.5%, %RSD for repeatability was 0.2 and 0.4, % RSD for intermediate precision was 0.5 and 0.1 respectively. The precision study was precise, robust, and repeatable. LOD value was 2.95 and 3.04, and LOQ value was 9.87 and 10 respectively.