SENSITIVE LC METHOD FOR SIMULTANEOUS DETERMINATION OF CICLESONIDE AND FORMOTEROL FUMARATE IN DRY POWDER INHALER

Abstract

A sensitive stability indicating reverse phase high performance liquid chromatographic method was developed for the simultaneous determination of formoterol fumarate and ciclesonide in dry powder inhaler. The chromatographic separation was achieved on Hypersil BDS C8 250 × 4.6 mm, 5 um column using a mobile phase consisting of 0.1% orthophospheric acid and acetonitrile in the ratio of 35:65 (v/v), at a flow rate of 2.0 mL min−1. The column compartment temperature was set at 40°C. The typical HPLC chromatograms were extracted at 214 nm using photodiode array detector (PDA). The described method shows excellent linearity over a range of 3.6 µg mL−1 to 1.1 ng mL−1 for formoterol fumarate and 120 µg mL−1 to 34 ng mL−1 for ciclesonide. The correlation coefficient for formoterol fumarate and ciclesonide was 0.9998. The limit of detection and limit of quantification for formoterol fumarate was 0.33 ng mL−1, 1.1 ng mL−1 and for ciclesonide 10.2 ng mL−1, 34 ng mL−1, respectively. The proposed method was found to be very sensitive and accurate for the determination of Formoterol Fumarate and ciclesonide indry powder inhaler.