Indian Journal of Chemical Technology, Vol.23, No.5, 405-411, 2016
Stability indicating LC method for estimation of Formoterol fumarate and Mometasone furoate in respicaps dosage form
A stability indicating high-performance liquid chromatographic (HPLC) method for simultaneous estimation of Formoterol fumarate and Mometasone furoate in respicaps has been represented. The chromatographic conditions employed for the estimation includes a reversed phase Inertsil C8 column (250 x 4.6 mm, 5 mu) at 25 degrees C, a mixture of ammonium acetate buffer solution (0.05M, pH 5.0) and acetonitrile (30:70) as mobile phase at 0.8mL/min flow rate and UV detection at 247 nm. The retention time of Formoterol fumarate and Mometasone furoate are found to be 3.06 min and 8.67 min, respectively. Linearity range for Formoterol fumarate and Mometasone furoate are found at 0.75-2.25 mu g/mL and 25-75 mu g/mL, respectively with good correlation coefficients. The sample solution undergoes significant degradation under acidic, basic and oxidation stress conditions. Chromatograms of the stress studies indicate that obtained peaks were spectrally pure during peak purity studies. The method is validated as per ICH guidelines for precision, accuracy and robustness studies. Results suggest that the developed methods can be efficiently used for routine quality control analysis as well as stability indicating assay of Formoterol fumarate and Mometasone furoate in respicaps.
Keywords:Formoterol fumarate;Mometasone furoate;Simultaneous estimation;Stability indicating assay method;HPLC;Validation