Sunday , 22 May 2022

Analytical Method Development and Validation for the Simultaneous Estimation of Fluticasone and Vilanterol by RP-HPLC Method in its Pharmaceutical Dosage Forms

Swapna1, P. Sowjanya1, Dr. Gampa Vijaya Kumar*2
1KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
2Professor and Head, Department of Pharmacy, KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.

A new method was established for simultaneous estimation of fluticasone and vilanterol by RP-HPLC method.  The chromatographicconditionsweresuccessfullydevelopedfortheseparationoffluticasone and vilanterol by using inertsil C185µm (4.6*250mm) column, flow rate was1ml/min, mobile phase ratio was Phosphate buffer (0.05M) pH4.6: CAN (30:70%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. There tention times were found to be 2.399mins and 3.907mins. The % purity of fluticasone and vilanterol was found tobe100.7% and 101.4% respectively. The system suitability parameters for fluticasone and vilanterol such as the or etical plates and tailing factor were found to be 1.3, 5117.5 and 1.4, 3877.3 there solution was found to be 8.0. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study for fluticasone and vilanterol was found  in  concentration  range   of  100μg-500μg  and  1μg-5μg   and correlation coefficient(r2) was found to be 0.997 and 0.999, %mean recovery was found to be 100%, 100.5%,% RSD for repeatability was 0.2 and 0.4,% RSD for intermediate precision was0.5and 0.1 respectively. The precision study was precise, robust, and repeatable. LOD value was 2.95 and 3.04 and LOQ value was 9.87and10 respectively. Hence the suggested RP-HPLC method can be used for routine analysis of fluticasone and vilanterol in API and Pharmaceutical dosage form.

Keywords: Fluticasone, Vilanterol, RP-HPLC

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