ABSTRACT A sensitive and simultaneous reversed phase‐HPLC quantification method was developed for complex combined pharmaceutical metered dose inhaler, containing fluticasone propionate (FP) and formoterol fumarate dihydrate (FFD) as active contents. The active contents were separated on Zorbax SB C18 3.5 µm, (4.6 × 75) mm in the presence of acetonitrile, methanol, and buffer solution (50:10:40) v/v as mobile phase containing sodium dodecyl sulfate and glacial acetic acid, at 220 nm. Samples were analyzed by inserting 80 µL volume at 50°C column temperature and 0.8 mL/min of flow. The developed method was validated in accordance with International Council for Harmonization guideline, applied for content per actuation, delivered dose uniformity and in‐vitro respirable fractions through aerodynamic particle size distribution. The method was found linear, precise, specific, and accurate for its intended purpose. The sensitive reversed phase‐HPLC method achieved with quantitation limit value 0.0050 and 0.0459 µg/mL of FFD and FP, respectively. Content per actuation, delivered dose and respirable fractions for FFD and FP was observed 100.4%, 100.0%, 2.062 mcg and 99.9%, 101.4%, 42.137 mcg, respectively. The method was effectively operated for the quantitation of FP and FFD, is very useful for regular quality control laboratory.
Chilka et al. (Wed,) studied this question.