Monday , 21 January 2019

RP-HPLC Method Development and Validation for Simultaenous Estimation of Montelukast and Fexofenadine Hydrochloride in Bulk and Pharmaceutical Dosage Form

L. Nikhil kumar*1, Chandan R.S2
1JSS Academy of Higher Education and Research, Mysore-570015, Karnataka, India.

2Department of Pharmaceutical Chemistry, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysore 570015 Karnataka, India.

A B S T R A C T
A new method was established for simultaneous estimation of Faxofenadine Hydrochloride Hydrochloride and Montelukast by RP-HPLC method.  The chromatographic conditions were successfully developed for the separation of Faxofenadine Hydrochloride and Montelukast by using Xterra C18 5µm (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 Waters HPLC Auto Sampler, Separation module 2695, PDA Detector 996, Empower-software version-2.The retention times were found to be 2.399mins and 3.907mins. The % purity of Faxofenadine Hydrochloride   and Montelukast was found to be 100.7% and 101.4% respectively. The system suitability parameters for Faxofenadine Hydrochloride 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 Faxofenadine Hydrochloride and Montelukast was found   in   concentration   range   of   1μg-5μg   and   100μg-500μg   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.

Keywords: Faxofenadine Hydrochloride and Montelukast, RP-HPLC method

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