title: Simultaneous quantitation of aspirin, amlodipine and simvastatin in a fixed dose combination of encapsulated tablet formulation by HPLC-UV method.
abstract: A high-pressure liquid chromatography (HPLC-UV) based simple and specific method for simultaneous quantitative determination of aspirin, amlodipine besylate and simvastatin in a capsule formulation has been developed and validated according to ICH guidelines. Chromatographic separation of the three drugs was carried out by aSpherisorbODS2 reverse phase column (4.6 x 250 mm; 5 μm) using amobile phase, which consisted of 70: 30 (v/v) mixture of acetonitrile and triethylamine phosphate buffer (pH 3; 0.015 M) with final pH adjusted to 2.5 using dilute ortho-phosphoric acid, at a flow rate of 1mL/min. The eluents were detected at UV wavelength of 237 nm and the retention times for aspirin, amlodipine besylate and simvastatin were ~2.7 mins, ~6.1 mins and ~10.5mins, respectively. This method is suitable and specific for the three drugs and was found to be linear (R2>0.995), accurate, specific, reproducible and robust in the concentration range of 375 to 1125mcg/ml for aspirin, 25 to 75mcg/ml for amlodipine besylate and 50 to 150mcg/ml for simvastatin. This simple and convenient method could be easily utilized for the characterization and quantitation of the three drugs in a single formulation for combination therapy of cardiovascular diseases.
authors.affiliation: Department of Pharmaceutics, Faculty of Pharmacy, University of Karachi, Karachi, Pakistan.
authors.forename: Faisal
authors.initials: F
authors.lastname: Sultan
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: Farrukh Rafiq
authors.initials: FR
authors.lastname: Ahmed
authors.affiliation: Department of Pharmaceutics, Faculty of Pharmacy, University of Karachi, Karachi, Pakistan.
authors.forename: Faseeh A
authors.initials: FA
authors.lastname: Salam
authors.affiliation: Department of Pharmaceutics, Faculty of Pharmacy, University of Karachi, Karachi, Pakistan.
authors.forename: Muhammad Iqbal
authors.initials: MI
authors.lastname: Nasiri
authors.affiliation: Department of Pharmaceutics, Faculty of Pharmacy, University of Karachi, Karachi, Pakistan.
authors.forename: Muhammad Atif
authors.initials: MA
authors.lastname: Khan
authors.affiliation: Department of Pharmaceutics, Faculty of Pharmacy, University of Karachi, Karachi, Pakistan.
authors.forename: Saeed
authors.initials: S
authors.lastname: Manzoor
mesh_terms: D017311:Amlodipine / Q000032:analysis*; D001241:Aspirin / Q000032:analysis*; D002317:Cardiovascular Agents / Q000032:analysis*; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D056148:Chromatography, Reverse-Phase; D004338:Drug Combinations; D057230:Limit of Detection; D015203:Reproducibility of Results; D019821:Simvastatin / Q000032:analysis*; D013056:Spectrophotometry, Ultraviolet; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000379:methods*
chemical_list: D002317:Cardiovascular Agents; D004338:Drug Combinations; D013607:Tablets; D017311:Amlodipine; D019821:Simvastatin; D001241:Aspirin