Abstract

SIMULTANEOUS ESTIMATION OF NEW ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF FLUTICASONE AND VILANTEROL BY RP-HPLC METHOD IN BULK AND MARKETED FORMULATION

U. Yogitha*, V. Swetha and J. Pavani

Abstract

A simple, accurate, precise method was developed for the simultaneous estimation of Fluticasone and Vilanterol inhalation dosage form. Chromatogram was run through STD Agilent C18 250 x 4.6 mm, 5. Mobile phase containing Buffer 0.1% OPA: Acetonitrile taken in the ratio 60:40 was pumped through column at a flow rate of 1.0 ml/min. Buffer used in this method was 0.1%OPA buffer. Temperature was maintained at 30°C. Optimized wavelength selected was 255nm. Retention time of Vilanterol and Fluticasone were found to be 2.199 min and 3.087. %RSD of the Fluticasone and Vilanterol were and found to be 0.8 and 0.5 respectively. %Recovery was obtained as 99.61% and 100.23% for Fluticasone and Vilanterol respectively. LOD, LOQ values obtained from regression equations of Fluticasone and Vilanterol were 0.48, 1.45and 0.28, 0.34 respectively. Regression equation of Fluticasone was y = 1509.9x + 2896.9 and for Vilanterol was y = 19667x + 2677.3.

Keywords: Method validation, Method development, RP-HPLC, Active pharmaceutical ingredient, Regression.