title: Isolation, identification and characterization of degradant impurities in Tolterodine tartrate formulation.
abstract: During the stability study of Tolterodine tartrate drug product, two unknown impurities (Impurities I and II) were detected by ultra performance liquid chromatography (UPLC). Both impurities were isolated by preparative liquid chromatography and were subjected to mass and NMR spectral studies. Based on the spectral data, the Impurities I and II were characterized as N-(3-(2-hydroxy-5-methylphenyl)-3-phenylpropyl)-N,N-diisopropyl hydroxyl ammonium trifluoro acetate and 3-(2-hydroxy-5-methylphenyl)-N-isopropyl-3-phenylpropane-1-amine oxide respectively.
authors.affiliation: Department of Analytical Research and Development, Dr. Reddy's Laboratories, Hyderabad 500 090, AP, India; Pharmaceutical Chemistry Division, School of Advanced Sciences, VIT University, Vellore 632014, TN, India. Electronic address: prakashlakkireddy@gmail.com.
authors.forename: Lakkireddy
authors.initials: L
authors.lastname: Prakash
authors.affiliation: Pharmaceutical Chemistry Division, School of Advanced Sciences, VIT University, Vellore 632014, TN, India.
authors.forename: M
authors.initials: M
authors.lastname: Himaja
authors.affiliation: Department of Analytical Research and Development, Dr. Reddy's Laboratories, Hyderabad 500 090, AP, India.
authors.forename: B Venkata
authors.initials: BV
authors.lastname: Subbaiah
authors.affiliation: Department of Analytical Research and Development, Dr. Reddy's Laboratories, Hyderabad 500 090, AP, India.
authors.forename: R
authors.initials: R
authors.lastname: Vasudev
authors.affiliation: Department of Analytical Research and Development, Dr. Reddy's Laboratories, Hyderabad 500 090, AP, India.
authors.forename: C
authors.initials: C
authors.lastname: Srinivasulu
authors.affiliation: Department of Analytical Research and Development, Dr. Reddy's Laboratories, Hyderabad 500 090, AP, India.
authors.forename: R
authors.initials: R
authors.lastname: Haribabu
mesh_terms: D001559:Benzhydryl Compounds / Q000032:analysis / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D003408:Cresols / Q000032:analysis / Q000737:chemistry*; D004340:Drug Contamination; D004355:Drug Stability; D009682:Magnetic Resonance Spectroscopy / Q000379:methods / Q000592:standards; D013058:Mass Spectrometry / Q000379:methods; D018727:Muscarinic Antagonists / Q000032:analysis / Q000737:chemistry* / Q000592:standards; D010665:Phenylpropanolamine / Q000032:analysis / Q000737:chemistry*; D000068737:Tolterodine Tartrate
chemical_list: D001559:Benzhydryl Compounds; D003408:Cresols; D018727:Muscarinic Antagonists; D010665:Phenylpropanolamine; D000068737:Tolterodine Tartrate
keywords: Identification; Impurity; Isolation; Spectral characterization; Tolterodine tartrate