title: LC determination of loratadine and related impurities.
abstract: Loratadine, an antihistamine, could include in its raw material seven impurities that ought to be separated identified and quantified for drug development and quality control. A HPLC method employing a SymmetryShield RP8 column has been developed and validated for loratadine and related compounds measurement, the last ones under the 0.1% level. The mobile phase consisted of methanol-buffer A (65:35, v/v), being buffer A: H(3)PO(4) 10 mM (H(2)O) brought up to pH 7.00 with triethylamine. UV detection was performed at 244 nm. Validation parameters for linearity, accuracy and precision are in agreement with ICH guidelines for all the analytes and that permits to consider the method reliable and suitable for application to long-term stability and purity studies.
authors.affiliation: Facultad de CC Experimentales y de la Salud, Universidad San Pablo-CEU Urbanización Montepríncipe, Ctra. Boadilla del Monte, km 5,3-28668 Madrid, Spain.
authors.forename: F J
authors.initials: FJ
authors.lastname: Rupérez
authors.forename: H
authors.initials: H
authors.lastname: Fernández
authors.forename: C
authors.initials: C
authors.lastname: Barbas
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D006634:Histamine H1 Antagonists / Q000032:analysis*; D017336:Loratadine / Q000032:analysis*; D015203:Reproducibility of Results; D013678:Technology, Pharmaceutical
chemical_list: D006634:Histamine H1 Antagonists; D017336:Loratadine