Author(s): Ravi Gowda, Padmakar A. Sathe
A simple, cost effective, sensitive, accurate and precise reverse phase high performance liquid chromatographic method is developed for the simultaneous determination of impurities in formoterol fumarate and aclidinium bromide in Duaklir Genuair (powder for inhalation) dosage form. Ascentis express C8, 15cm x 4.6mm, 2.7 µ i.d in gradient mode, with mobile phase containing 2% trimethylamine pH adjusted to 3 Orthophosphoric acid, acetonitrile (85:15 v/v) was used. A flow rate of 1.0mL/min and detection was carried out with 250 nm. The retention times of formoterol fumarate and aclidinium bromide were the 4.3 and 6.6min, respectively. The method is validated by determining its sensitivity, precision, linearity, accuracy. The proposed method is simple, rapid, sensitive, accurate and precise and so that it can be applied for routine quality control analysis of formoterol fumarate and aclidinium bromide in Duaklir Genuair (powder for inhalation) dosage forms.