Abstract

STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF FLUTICASONE AND VILANTEROL IN BULK AND PHARMACEUTICAL FORMULATION

Aruna Gundala*, Hari Krishna Y. and Jayachandra Reddy P.

ABSTRACT

The present study was designed to develop and validate a simple, sensitive, precise and accurate stability indicating RP-HPLC method for simultaneous estimation of fluticasone and vilanterol in bulk and tablet dosage form. The chromatographic separation was achieved on Zodiac C18 column (250 x 4.6 mm, 5μm) as stationary phase with a mobile phase of water (PH 5.4 adjusted with ortho phosphoric acid):acetonitrile (60:40 v/v) at a flow rate of 1 ml/min and PDA detection at 255 nm. The proposed method was validated for system suitability, specificity, linearity, accuracy, precision, LOD, LOQ and robustness as per ICH guidelines. The retention times of fluticasone and vilanterol were found to be 2.528± 0.04 and 3.782± 0.07 min respectively. The calibration curves were linear in the concentration range of 50% to 150% of the working concentration (r2=0.999) for both the drugs in binary mixture. The accuracy was found to be 99.26% and 99.45 % for fluticasone and vilanterol respectively. The LOD was found to be 0.19μg/ml and 0.12μg/ml and LOQ was found to be 0.57 μg/ml and 0.36 μg/ml for fluticasone and vilanterol respectively. The percentage recoveries for both drugs were in the range of 99-100%. Hence the proposed stability indicating RP-HPLC method can be used in routine analysis of tablets containing fluticasone and vilanterol.

Keywords: Fluticasone, Vilanterol, RP-HPLC, stability, Method development and Validation.