A Novel Stress Indicating RP-HPLC Method Development and Validation for the Simultaneous Estimation of Aclidinium and Formoterol in bulk and its Tablet Dosage Forms

Abstract

A simple reversed-phase high performance liquid chromatographic method was Developed for the simultaneous estimation of the Aclidinium and formoterol in bulk and its tablet dosage form. The method was developed on Dikma Spursil, C₁₈ column (4.6 x 150mm, 5µ) particle size, wavelength was fixed at 280nm with photo diode array detection. The mobile phase was consisted mixture of Buffer: Acetonitrile (30: 70), pH 4.3 was adjusted with hydrochloric acid and flow of mobile phase through the column was maintained 1mL/min. The retention times of Aclidinum and Formoterol were found to be 3.04 and 4.45 min respectively. The method was statistically validated with concern of precision, linearity, range and robustness of method was found for Aclidinumand Formoterol. The above method was afforded excellent percentage recovery was found to be 99.87-100.22%& 99.68-100.17% for Aclidinum and Formoterol respectively. The Limit of detection & Limit of quantification were found 0.10,0.34µg/ml and 0.16, 0.53 µg/ml for Aclidinum and Formoterol. The forced degradation studies were performed. A new simple, selective, reproducible, rapid and accurate reversed phase liquid chromatographic method was developed and validated for the estimation of Aclidinum and Formoterol.