title: Simultaneous quantitation of Ofloxacin, Fexofenadine HCl and Diclofenac Potassium in affixed dose combinative formulation by HPLC-UV method.
abstract: A high-pressure liquid chromatography (HPLC-UV) based simple and specific method for simultaneous quantitative determination of Ofloxacin, Fexofenadine HCl and Diclofenac Potassium has been developed and validated according to ICH guidelines. Chromatographic separation of the three drugs was carried out on 4.6 x 250 mm x 5 µ Licrospher RP Select B Column, using mobile phase constituted of methanol and phosphate buffer pH 3.5 (650: 350), pH adjusted to 3.5 ± 0.05 with dilute ortho-phosphoric acid and delivered at a flow rate of 1 ml/min. The eluents were detected at UV wavelength of 220 nm and the retention times for Ofloxacin, Fexofenadine HCl and Diclofenac Potassium were 2.5 minutes, 4 minutes and 11.5 minutes, respectively. This method is suitable and specific for the three drugs and was found to be linear (R² > 0.996), accurate, specific, reproducible and robust over a concentration range of 0.05 to 0.15 mg/ml for Ofloxacin, 0.015 to 0.045 mg/ml for Fexofenadine HCl and 0.0125 to 0.0375 mg/ml for Diclofenac Potassium. The proposed method is simple and convenient, hence easily utilized for the characterization and quantitation of the three drugs in a single formulation for combination therapy of rheumatoid arthritis, sepsis, infection with fever and flu.
authors.affiliation: Department of Pharmaceutics, Faculty of Pharmacy, University of Karachi, Karachi, Pakistan.
authors.forename: Faseeh Abdus
authors.initials: FA
authors.lastname: Salam
authors.affiliation: Department of Pharmaceutics, Faculty of Pharmacy, University of Karachi, Karachi, Pakistan.
authors.forename: Muhammad Harris
authors.initials: MH
authors.lastname: Shoaib
authors.affiliation: Department of Pharmaceutics, Faculty of Pharmacy, University of Karachi, Karachi, Pakistan.
authors.forename: Rabia Ismail
authors.initials: RI
authors.lastname: Yousuf
authors.affiliation: Department of Pharmaceutics, Faculty of Pharmacy, University of Karachi, Karachi, Pakistan.
authors.forename: Faisal
authors.initials: F
authors.lastname: Sultan
authors.affiliation: Sanofi-Aventis Pakistan Limited Plot 23, Sector 22 Korangi Industrial Area, Karachi, Pakistan.
authors.forename: Muhammad Atif
authors.initials: MA
authors.lastname: Khan
authors.affiliation: Martin Dow Limited, Plot 37, Sector19, Korangi Industrial Area, Karachi, Pakistan.
authors.forename: Saeed
authors.initials: S
authors.lastname: Manzoor
mesh_terms: D000900:Anti-Bacterial Agents / Q000032:analysis*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000032:analysis*; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D004008:Diclofenac / Q000032:analysis*; D004338:Drug Combinations; D039563:Histamine H1 Antagonists, Non-Sedating / Q000032:analysis*; D015242:Ofloxacin / Q000032:analysis*; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet; D016593:Terfenadine / Q000031:analogs & derivatives* / Q000032:analysis
chemical_list: D000900:Anti-Bacterial Agents; D000894:Anti-Inflammatory Agents, Non-Steroidal; D004338:Drug Combinations; D039563:Histamine H1 Antagonists, Non-Sedating; D004008:Diclofenac; D016593:Terfenadine; D015242:Ofloxacin; C093230:fexofenadine