Monday , 20 May 2024

A Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Montelukast and Fexofenadine Hydrochloride in Bulk and Pharmaceutical Dosage Form

Dr. Gampa Vijay Kumar1*, Dr. T. Rajesh2, Jaya Chandhra3
1Professor and Head, Dept. of Pharmacy, KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.2KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.

A  B  S  T  R A C T
A new method was established for simultaneous estimation of Faxofenadine and Montelukast by RP-HPLC method.  The chromatographic conditionsweresuccessfullydevelopedfortheseparationofFaxofenadine and Montelukast by using XterraC185µm(4.6*250mm)column, flow rate was1ml/min, mobile phase ratio was Phosphate buffer (0.05M)pH4.6: ACN  (55:45%v/v)  (pH  was   adjusted  with  orthophosphoric  acid), detection wavelength 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 Faxofenadine and Montelukast was found to be100.7% and 101.4%respectively.The system suitability parameters for Faxofenadine and Montelukast such as theoretical plates and tailing factor were found to be 1.3, 5117.5and1.4,3877.3the resolution was foundtobe8.0.Theanalyticalmethodwas validated according to ICH guidelines (ICH,Q2(R1)).The linearity study for Faxofenadine and Montelukast was found  in  concentration  range   of  1μg-5μg  and  100μg-500μg   and correlation coefficient (r2) was found to be 0.999and 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 0.5and 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.
Keyword: Faxofenadine and Montelukast, RP-HPLC method

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