Development, Validation and Green Analytical Assessment of a Stability-Indicating RP-HPLC Method for Simultaneous Estimation of Glycopyrronium, Vilanterol and Fluticasone Furoate in Capsule Dosage Form
Oct 2026· Asian Journal of Pharmaceutical Research· Vol 16, pp. 371· 0 citations· 11 references
TL;DR
For simultaneous evaluation of glycopyrronium, vilanterol, and fluticasone furoate in capsules, an Inertsil ODS C18 column was used to develop a reverse-phase HPLC technique that was stability-indicating and sufficient for pharmacopeial quality control of the marketed formulation.
Abstract
For simultaneous evaluation of glycopyrronium, vilanterol, and fluticasone furoate in capsules, an Inertsil ODS C18 column was used to develop a reverse-phase HPLC technique. Acetonitrile (ACN) and 0.1% triethylamine (Et3N), pH 2.5, were used as a mobile phase in a 20:80 volumetric ratio to achieve separation with 1.0ml/min, at retention times of about 2.25, 3.02 and 4.38min for glycopyrronium, vilanterol and fluticasone furoate, respectively, with detection at 250nm. Validation in compliance with ICH guidelines verified adequate accuracy, precision, linearity, specificity and robustness, and forced degradation findings confirmed that the method was stability-indicating and sufficient for pharmacopeial quality control of the marketed formulation. Green assessment using the AGREE tool yielded a score of 0.58, supporting its routine use for quality control and stability evaluation of this triple combination.
A simple, accurate, precise, and stability-indicating RP-HPLC method was developed and validated for the simultaneous estimation of Dapagliflozin (DAPA) and Vildagliptin (VILDA) in a combined tablet dosage form using a Quality by Design approach. Method development was carried out systematically by identifying importan...
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A validated reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed for the simultaneous identification and quantification of metronidazole benzoate, diloxanide furoate, methylparaben, and propylparaben in combined pharmaceutical suspensions. Chromatographic separation was achieved using a...
Ibrahim Sharhan, W. Al-Madhagi, Ahmed M. Sabati et al.· Journal of Science and Mathe...· 0 citations
Application of the validated method to commercial herbal weight-loss supplements successfully identified products adulterated with sibutramine and desmethylsibutramine, and all positive findings were independently confirmed by high-resolution mass spectrometry.
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Methods: Chromatographic separa...
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