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ISRN Analytical Chemistry
Volume 2013 (2013), Article ID 834240, 7 pages
http://dx.doi.org/10.1155/2013/834240
Research Article

Development and Validation of High Performance Liquid Chromatography Method for Simultaneous Estimation of Ambroxol and Doxofylline in Their Combined Tablet Dosage Form

1Vidyasthali Institute of Technology, Science and Management, Durgapura, Jaipur, Rajasthan 302018, India
2Geetanjali Institute of Pharmacy, Geetanjali University, Udaipur, Rajasthan 313002, India

Received 3 June 2013; Accepted 27 June 2013

Academic Editors: A. Bouklouze, D. Kara, and A. Orte

Copyright © 2013 Neha Singhal et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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.