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<p>Fluticasone furoate (FF) and vilanterol trifenatate (VT) combination drugs formulations are used worldwide in the treatment of lung-related diseases. Anew, specific, stability-indicating RP-HPLC method for the quantification of known impurities with relative response factor (RRF) and unknown degradants has been successfully established. Good resolution was achieved on a BakerBond phenyl hexyl (250 mm × 4.6 mm, 5 μm) column, in a gradient elution mode using mobile phase A (mixture of sodium dihydrogen orthophosphate and 1-octane sulfonic acid sodium salt at pH 2.5) and mobile phase B (acetonitrile and methanol 80:20 about.%) at 0.8 ml/min flow. The FF and VT impurities quantitated at 242 nm and 220 nm, respectively. For the known and unknown impurities, a very sensitive limit of detection (LOD) and limit of quantification (LOQ) were established. The method was found to be linear from LOQ to 150% of impurities specification level with r2 values of 0.9943 – 1.0000. Recovery for LOQ level 96.2 – 108.2% and at 50%, 100%, 150% levels 91.3 – 107.4% were found. %RSD of precision study was 1.15 – 11.81%. The solutions were stable up to 48 h at 25°C. The newly developed HPLC method can be successfully used in the quality control laboratories of pharmaceutical industries for release testing and stability studies, etc., of the commercial batches.</p>

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Impurity Profiling Method Development, Validation, and Relative Response Factor Estimation for Fluticasone Furoate and Vilanterol Trifenatate Dry Powder Inhaler Using RP-HPLC with UV/PDA Detector

  • 期刊论文

  • 发表日期：

    2025年8月1日

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  • S. V. Kulkarni,
  • V. R. Gulave,
  • B. D. Musmade,
  • S. G. Bhope,
  • M. Nagar,
  • Sharad P. Panchgalle,
  • V. S. More

摘要

Fluticasone furoate (FF) and vilanterol trifenatate (VT) combination drugs formulations are used worldwide in the treatment of lung-related diseases. Anew, specific, stability-indicating RP-HPLC method for the quantification of known impurities with relative response factor (RRF) and unknown degradants has been successfully established. Good resolution was achieved on a BakerBond phenyl hexyl (250 mm × 4.6 mm, 5 μm) column, in a gradient elution mode using mobile phase A (mixture of sodium dihydrogen orthophosphate and 1-octane sulfonic acid sodium salt at pH 2.5) and mobile phase B (acetonitrile and methanol 80:20 about.%) at 0.8 ml/min flow. The FF and VT impurities quantitated at 242 nm and 220 nm, respectively. For the known and unknown impurities, a very sensitive limit of detection (LOD) and limit of quantification (LOQ) were established. The method was found to be linear from LOQ to 150% of impurities specification level with r2 values of 0.9943 – 1.0000. Recovery for LOQ level 96.2 – 108.2% and at 50%, 100%, 150% levels 91.3 – 107.4% were found. %RSD of precision study was 1.15 – 11.81%. The solutions were stable up to 48 h at 25°C. The newly developed HPLC method can be successfully used in the quality control laboratories of pharmaceutical industries for release testing and stability studies, etc., of the commercial batches.