Key points are not available for this paper at this time.
A novel RP-HPLC approach was developed for the synchronous estimation of Vilanterol and Fluticasone. To optimize chromatographic variables, a mobile phase consisting of methanol: ACN: phosphate buffer pH 7 (60:20:20% v/v) was employed with a stationary phase of a Water BEH X Bridge C18 column (250 mm × 4.6 mm, 5 μ) at a flow rate of 1 mL/min. The temperature of the column was maintained at 40°C, and the isosbestic point of these two drugs was detected at 280 nm. An isocratic elution, well-resolved excellent peak symmetry was obtained for both molecules in less than 10 minutes. The retention times of fluticasone furoate and vilanterol trifenatate were determined to be 4.232 and 3.539 minutes, respectively. The calibration curves were linear in concentration ranges of 50 µg-250 µg for vilanterol trifenatate and 5 µg-25 µg for fluticasone furoate, with mean % recoveries of 99–100%. The suggested method was validated in accordance with ICH Q2 (R1) guidelines. For vilanterol trifenatate, the limits of detection and quantitation are 0.39 and 0.7 μg/mL, while for fluticasone furoate, they are 1.18 and 2.12 μg/mL, respectively. As a result, the suggested RP-HPLC method was effective in quantifying the two-compound inhalation formulation.
R. Chandrasekar (Wed,) studied this question.