Volume : 08, Issue : 02, February – 2021
08.STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF FLUTICASONE FUROATE AND VILANTEROL TRIFENATATE BY RP-UPLC
Kondeti. Haritha Pavani*, Dannana. Gowri Sankar
Abstract :
A simple, accurate, precise method was developed for the simultaneous estimation of the Fluticasone furoate (FLU) and Vilanterol trifenatate (VIL) in bulk and pharmaceutical dosage form by using UPLC. Combination of Fluticasone furoate and Vilanterol trifenatate is used for treatment of bronchospasm associated with chronic obstructive pulmonary disease. Chromatography was carried out using BEH 100 x 2.1mm, 1.8µm. column with a flow rate of 0.3 mL/min. The mobile phase consisted of 0.01N Na2HPO4 Buffer of pH 4.0 and Acetonitrile in the ratio of 50:50. The retention times of FLU and VIL were found to be 1.206 min and 1.582 min respectively. Temperature was maintained at 30°C. Optimized wavelength for FLU and VIL was 260nm. The method developed has been statistically validated according to ICH guidelines. % RSD of FLU and VIL were and found to be 1.2 and 0.6 respectively. % Recovery was obtained as 100.13% and 99.82% for FLU and VIL respectively. LoD, LoQ values were obtained from regression equations of Fluticasone furoate and Vilanterol trifenatate were 0.10 ppm, 0.30 ppm and 1.51 ppm, 4.56 ppm respectively. The method obeys Beer’s law in the concentration range of 25-150 μg/mL (R2 = 0.999) for FLU, and 6.25-37.5 μg/mL (R2 = 0.999) for VIL. The method showed good reproducibility and recovery with % RSD less than 2. The stability-indicating capability of the method was established by forced degradation studies under stress conditions like acid, base, peroxide, UV, thermal, humidity. Retention times were decreased and that run time was decreased. Hence, the chromatographic method developed was simple and economical that can be adopted in regular quality control test in Industries and it is said to be rapid, specific, sensitive, robust, and reliable that can be effectively applied for routine analysis in research institutions, quality control departments in industries.
Key Words: Fluticasone furoate, Vilanterol trifenatate, RP-UPLC.
Cite This Article:
Please cite this article in press Kondeti. Haritha Pavani et al, Stability Indicating Method Development And Validation For The Estimation Of Fluticasone Furoate And Vilanterol Trifenatate By RP-UPLC., Indo Am. J. P. Sci, 2021; 08(02).