title: Simultaneous determination of rosuvastatin and atorvastatin in human serum using RP-HPLC/UV detection: method development, validation and optimization of various experimental parameters.
abstract: A novel, precise, accurate and rapid isocratic reversed-phase high performance liquid chromatographic/ultraviolet (RP-HPLC/UV) method was developed, optimized and validated for simultaneous determination of rosuvastatin and atorvastatin in human serum using naproxen sodium as an internal standard. Effect of different experimental parameters and various particulate columns on the analysis of these analytes was evaluated. The method showed adequate separation for rosuvastatin and atorvastatin and best resolution was achieved with Brownlee analytical C18 column (150×4.6 mm, 5 μm) using methanol-water (68:32, v/v; pH adjusted to 3.0 with trifluoroacetic acid) as a mobile phase at a flow rate of 1.5 ml/min and wavelength of 241 nm. The calibration curves were linear over the concentration ranges of 2.0-256 ng/ml for rosuvastatin and 3.0-384 ng/ml for atorvastatin. The lower limit of detection (LLOD) and lower limit of quantification (LLOQ) for rosuvastatin were 0.6 and 2.0 ng/ml while for atorvastatin were 1.0 and 3.0ng/ml, respectively. All the analytes were separated in less than 7.0 min. The proposed method could be applied for routine laboratory analysis of rosuvastatin and atorvastatin in human serum samples, pharmaceutical formulations, drug-drug interaction studies and pharmacokinetics studies.
authors.affiliation: Department of Pharmacy, University of Peshawar, Peshawar -25120, Pakistan.
authors.forename: Yasar
authors.initials: Y
authors.lastname: Shah
authors.forename: Zafar
authors.initials: Z
authors.lastname: Iqbal
authors.forename: Lateef
authors.initials: L
authors.lastname: Ahmad
authors.forename: Abad
authors.initials: A
authors.lastname: Khan
authors.forename: Muhammad Imran
authors.initials: MI
authors.lastname: Khan
authors.forename: Shabnam
authors.initials: S
authors.lastname: Nazir
authors.forename: Fazli
authors.initials: F
authors.lastname: Nasir
mesh_terms: D000069059:Atorvastatin; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D056148:Chromatography, Reverse-Phase / Q000379:methods*; D004355:Drug Stability; D005464:Fluorobenzenes / Q000097:blood*; D006538:Heptanoic Acids / Q000097:blood*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D016014:Linear Models; D000432:Methanol; D011743:Pyrimidines / Q000097:blood*; D011758:Pyrroles / Q000097:blood*; D015203:Reproducibility of Results; D000068718:Rosuvastatin Calcium; D012680:Sensitivity and Specificity; D013449:Sulfonamides / Q000097:blood*; D014867:Water
chemical_list: D005464:Fluorobenzenes; D006538:Heptanoic Acids; D011743:Pyrimidines; D011758:Pyrroles; D013449:Sulfonamides; D014867:Water; D000068718:Rosuvastatin Calcium; D000069059:Atorvastatin; D000432:Methanol