title: Impurity profile study of loratadine.
abstract: Three unknown impurities in loratadine bulk drug at levels below 0.1% (ranging from 0.05 to 0.1%) were detected by a simple isocratic reversed-phase high performance liquid chromatography (HPLC). These impurities were isolated from mother liquor sample of loratadine using reversed-phase preparative HPLC. Based on the spectral data (IR, NMR and MS) the structures of these impurities were characterized as 11-(N-carboethoxy-4-piperidylidene)-6,11-dihydro-5H-benzo(5,6) cyclopenta(1,2-b)-pyridine (I), 8-bromo-11-(N-carboethoxy-4-piperidylidene)-6,11-dihydro-5H-benzo(5,6) cyclopenta (1,2-b)-pyridine (II) and 8-chloro-11-(N-carboethoxy-4-piperidylidene)-5H-benzo(5,6) cyclopenta (1,2-b)-pyridine (III). The synthesis of these impurities was discussed.
authors.affiliation: Department of Analytical Research, Discovery Research Division, Dr Reddy's Laboratories Ltd., Bollaram Road, Miyapur, Hyderabad 500 050, India.
authors.forename: K V S R Krishna
authors.initials: KV
authors.lastname: Reddy
authors.forename: J Moses
authors.initials: JM
authors.lastname: Babu
authors.forename: Y Ravindra
authors.initials: YR
authors.lastname: Kumar
authors.forename: S Vishnu Vardhan
authors.initials: SV
authors.lastname: Reddy
authors.forename: M Kishore
authors.initials: MK
authors.lastname: Kumar
authors.forename: S
authors.initials: S
authors.lastname: Eswaraiah
authors.forename: K Rama Subba
authors.initials: KR
authors.lastname: Reddy
authors.forename: M Sayanarayana
authors.initials: MS
authors.lastname: Reddy
authors.forename: B Vijaya
authors.initials: BV
authors.lastname: Bhaskar
authors.forename: P K
authors.initials: PK
authors.lastname: Dubey
authors.forename: K
authors.initials: K
authors.lastname: Vyas
mesh_terms: D002851:Chromatography, High Pressure Liquid; D004340:Drug Contamination; D039563:Histamine H1 Antagonists, Non-Sedating / Q000032:analysis / Q000737:chemistry*; D017336:Loratadine / Q000032:analysis / Q000737:chemistry*; D009682:Magnetic Resonance Spectroscopy; D013058:Mass Spectrometry; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D017550:Spectroscopy, Fourier Transform Infrared
chemical_list: D039563:Histamine H1 Antagonists, Non-Sedating; D017336:Loratadine