REVERSE PHASE LIQUID CHROMATOGRAPHIC METHOD FOR ANALYSIS OF DOXOFYLLINE IN PRESENCE OF ITS DEGRADATION PRODUCTS
Nirmal Chaudhary, M Alam
Karnali College of Health Sciences (Purbanchal University), Kathmandu-44600, Nepal
Keywords: Doxofylline, Forced degradation studies, Method development, Validation
Abstract

A simple, precise and novel reverse phase liquid chromatographic method for analysis of doxofylline in bulk drug as well as in pharmaceutical preparations in the presence of potential degradation products of doxofylline has been developed and validated. Forced degradation studies were carried on doxofylline in acidic, neutral and alkaline hydrolytic conditions in addition to oxidative, thermal and photolytic conditions. Optimum separation among doxofylline and its degradation products was achieved using a ternary mixture of water: methanol: ethyl acetate in the ratio of 80:10: 10 % v/v/v as the mobile phase at a flow rate of 1.0 ml/min on a Supelco C18 DB 150 mm X 4.6 mm column as the stationary phase when scanned at a wavelength of 277 nm. The retention time for the various degradation products were found to be sufficiently different with each other as well as with the parent drug at the optimized chromatographic conditions to permit their accurate quantitative estimation. The method was found to be linear at least in the range of 5-25 µg/ml. The developed method was then validated for precision, accuracy, specificity, robustness and ruggedness in accordance with the ICH guidelines and other available regulatory guidelines.

Article Information

Identifiers and Pagination:
Year:2014
Volume:6
First Page:187
Last Page:197
Publisher Id:JAppPharm (2014 ). 6:3. 187-197
Article History:
Received:March 20, 2014
Accepted:March 28, 2014
Collection year:2014
First Published:April 1, 2014


© 2016 The Author(s). This open access article is distributed under a Creative Commons Attribution (CC-BY) 4.0 license. You are free to: Share — copy and redistribute the material in any medium or format Adapt — remix, transform, and build upon the material for any purpose, even commercially. The licensor cannot revoke these freedoms as long as you follow the license terms. Under the following terms: Attribution — You must give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use. No additional restrictions You may not apply legal terms or technological measures that legally restrict others from doing anything the license permits
Editor in Chief
Prof. Dr. Cornelia M. Keck (Philipps-Universität Marburg)
Marburg, Germany

Bibliography

Welcome to the research group of Prof. Dr. Cornelia M. Keck in Marburg. Cornelia M. Keck is a pharmacist and obtained her PhD in 2006 from the Freie Universität (FU) in Berlin. In 2009 she was appointed as Adjunct Professor for Pharmaceutical and Nutritional Nanotechnology at the University Putra Malaysia (UPM) and in 2011 she obtained her Venia legendi (Habilitation) at the Freie Universität Berlin and was appointed as a Professor for Pharmacology and Pharmaceutics at the University of Applied Sciences Kaiserslautern. Since 2016 she is Professor of Pharmaceutics and Biopharmaceutics at the Philipps-Universität Marburg. Her field of research is the development and characterization of innovative nanocarriers for improved delivery of poorly soluble actives for healthcare and cosmetics. Prof. Keck is executive board member of the German Association of Nanotechnology (Deutscher Verband Nanotechnologie), Vize-chairman of the unit „Dermocosmetics“ at the German Society of Dermopharmacy, active member in many pharmaceutical societies and member of the BfR Committee for Cosmetics at the Federal Institute for Risk Assessment (BfR).

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