title: Study of doxofylline and its degradation products in bulk drug by a newly developed stability-indicating HPLC method.
abstract: The purpose of this work was to study the stability behavior of doxofylline under different stress conditions and to develop a sensitive stability-indicating HPLC assay method. The stress conditions applied included heat, moisture, acid-base hydrolysis, oxidation, and UV light. The drug was particularly labile under oxidative and thermal stress conditions, with 58.40 and 53.90% degradation, respectively. Good resolution of drug from degradation products formed under stress conditions was achieved on a C18 column using 10 mM KH2PO4 buffer solution (pH 6) methanol (40 + 60, v/v) as the mobile phase (pH 7.2). The flow rate was 1 mLlmin, and the detection wavelength was 273 nm. The method was validated for linearity, range, precision, accuracy, LOD, and LOQ. The RSD was found to be <2%. Since the method effectively separates the drug from its degradation products, it can be used as a stability-indicating method.
authors.affiliation: Prin. K.M. Kundnani College of Pharmacy, Department of Pharmaceutical Analysis, Jote Joy Building, Rambhau Salgaonkar Marg, Cuffe Parade, Colaba, Mumbai-400 005, India.
authors.forename: Priti S
authors.initials: PS
authors.lastname: Patil
authors.forename: Purnima D
authors.initials: PD
authors.lastname: Hamrapurkar
authors.forename: Mitesh D
authors.initials: MD
authors.lastname: Phale
authors.forename: Masti I
authors.initials: MI
authors.lastname: Desai
authors.forename: Sandeep B
authors.initials: SB
authors.lastname: Pawar
mesh_terms: D001993:Bronchodilator Agents / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004355:Drug Stability; D013806:Theophylline / Q000031:analogs & derivatives* / Q000032:analysis / Q000737:chemistry
chemical_list: D001993:Bronchodilator Agents; D013806:Theophylline; C029797:doxofylline