Abstract
The present study described a new, simple, accurate, and precise high performance liquid chromatography method for the simultaneous determination of Ambroxol and Doxofylline in combined tablet dosage form. The chromatographic method was standardized using a BDS hypersil C18, 250 mm × 4.6 mm, 5 μ (particle size), Thermo scientific from Germany with isocratic conditions, and mobile phase containing potassium dihydrogen orthophosphate buffer-pH 4.5 (0.05 M KH2PO4): acetonitrile (60 : 40) at flow rate of 1 ml/min using UV detection at 254 nm. The retention times of Ambroxol and Doxofylline were 3.510 min and 7.247 min, respectively. The method was linear over the concentration range for Ambroxol 3.75–11.25 μg/mL and for Doxofylline 50-150 μg/mL. The recovery of Ambroxol and Doxofylline was found to be in the range of 99.42–101.18% and 99.37–100.28%, respectively. The validation of method was carried out using ICH guidelines. The described HPLC method was successfully employed for the analysis of pharmaceutical formulations containing combined dosage form.
Highlights
Ambroxol is a secretolytic agent used in the treatment of tracheobronchitis, emphysema with bronchitis pneumoconiosis, chronic inflammatory pulmonary conditions, bronchiectasis, and bronchitis with bronchospasm asthma [1]
Ambroxol and Doxofylline were dissolved in polar solvent, so the developed method of estimation was called as reverse phase high performance liquid chromatography
To develop a rugged and suitable HPLC method for the quantitative determination of Ambroxol and Doxofylline, the analytical condition was selected after the consideration of different parameters such as diluent, buffer, buffer concentration, organic solvent for mobile phase and mobile phase composition, and other chromatographic conditions
Summary
Ambroxol is a secretolytic agent used in the treatment of tracheobronchitis, emphysema with bronchitis pneumoconiosis, chronic inflammatory pulmonary conditions, bronchiectasis, and bronchitis with bronchospasm asthma [1]. Literature survey revealed that few spectroscopic methods RP-HPLC, HPTLC, and UPLC [3–10] methods have been reported for the estimation of Ambroxol with other drugs. It is mainly used for maintenance therapy in patients suffering from asthma and Chronic Obstructive Pulmonary Disease (COPD). Literature survey revealed that few spectrophotometric methods and RP-HPLC method have been reported for the estimation of Doxofylline with other drugs [12–15]. An attempt has been made to develop new HPLC method which is simple, rapid, reproducible, and economical method for simultaneous estimation of Ambroxol and Doxofylline in tablet dosage form
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
