Development and validation of stability indicating RP-HPLC method for fluticasone furoate and vilanterol in pharmaceutical formulations
By: Masimukku, S. K
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Contributor(s): Chintala, R.
Publisher: Mumbai Indian Drug Manufacture's Association - IDMA 2018Edition: Vol. 55 (03) March.Description: 27-31.Subject(s): PHARMACEUTICS | Method development and validationOnline resources: Click here
In:
Indian drugsSummary: A simple, rapid, accurate and stability indicating High Performance Liquid Chromatographic method was developed and validated for the simultaneous determination of vilanterol (VTL) and fluticasone furoate (FFE) in pure and in pharmaceutical formulations using C18 Column and methanol: acetonitrile: 1% sodium perchlorate in the ratio 50:40:10 v/v/v as mobile phase at pH 4.8 and flow rate of 1 mL/min with isocratic elution. The eluted compounds were detected using UV7000 detector at a wavelength of 254nm. The retention times of VTL and FFE were found to be 4.54 and 7.65 min, respectively, with a correlation coefficient of 0.9990 each. The linearity ranges for VTL and FFE were found to be 2.5–15μg/ml and 10–60μg/ml respectively. The LOD and LOQ values were observed to be 0.001μg/mL and 0.02μg/mL for VTL and 0.005μg/mL and 0.07μg/mL for FFE. The percentage recovery was found to be in range of 98.37 – 99.84 % and 98.46 –101.42 % for VTL and FFE, respectively. Both the drugs were subjected to acid, base, hydrolysis, oxidation, photolytic and thermal degradation conditions. The degradation products of VTL and FFE were well resolved from the pure drug with significant differences in their retention time values. This validated method was applied for the simultaneous estimation of VTL and FFE in a commercially available formulation sample.
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A simple, rapid, accurate and stability indicating High Performance Liquid Chromatographic method was developed and validated for the simultaneous determination of vilanterol (VTL) and fluticasone furoate (FFE) in pure and in pharmaceutical formulations using C18 Column and methanol: acetonitrile: 1% sodium perchlorate in the ratio 50:40:10 v/v/v as mobile phase at pH 4.8 and flow rate of 1 mL/min with isocratic elution. The eluted compounds were detected using UV7000 detector at a wavelength of 254nm. The retention times of VTL and FFE were found to be 4.54 and 7.65 min, respectively, with a correlation coefficient of 0.9990 each. The linearity ranges for VTL and FFE were found to be 2.5–15μg/ml and 10–60μg/ml respectively. The LOD and LOQ values were observed to be 0.001μg/mL and 0.02μg/mL for VTL and 0.005μg/mL and 0.07μg/mL for FFE. The percentage recovery was found to be in range of 98.37 – 99.84 % and 98.46 –101.42 % for VTL and FFE, respectively. Both the drugs were subjected to acid, base, hydrolysis, oxidation, photolytic and thermal degradation conditions. The degradation products of VTL and FFE were well resolved from the pure drug with significant differences in their retention time values. This validated method was applied for the simultaneous estimation of VTL and FFE in a commercially available formulation sample.
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