title: Simultaneous quantification of related substances of perindopril tert-butylamine using a novel stability indicating liquid chromatographic method.
abstract: A novel stability indicating gradient reverse-phased high-performance liquid chromatographic method has been developed for the quantification of impurities of perindopril tert-butylamine (PER) in pharmaceutical dosage form. Separation of the active substance and its known (Impurities B, C, D, E, F) and unknown impurities was achieved on a BDS Hypersil C18 column (250 mm × 4.6 mm, 5 µm), thermostated at 70°C, using a mobile phase comprised of aqueous solution of sodium 1-heptanesulfonate adjusted to pH 2 with perchloric acid and acetonitrile. The flow rate was maintained at 1.5 mL min(-1), injection volume of 20 µL was utilized and detection of analytes was performed at 215 nm. The developed method was validated in accordance with current ICH Guidelines for all suggested parameters, including forced degradation studies and proved to be linear, accurate, precise and suitable for the impurity testing of PER, being subsequently applied during on-going stability studies of a newly developed generic formulation.
authors.affiliation: Department of Pharmaceutical Industry and Biotechnology, Faculty of Pharmacy, University of Medicine and Pharmacy of Tîrgu Mureş, Gheorghe Marinescu 38, Tîrgu Mureş RO-540139, Romania szabo.zoltan@umftgm.ro.
authors.forename: Zoltán-István
authors.initials: ZI
authors.lastname: Szabó
authors.affiliation: Vim Spectrum, Sos. Sighisoarei 409, Corunca, Romania.
authors.forename: Zenkő-Zsuzsánna
authors.initials: ZZ
authors.lastname: Réti
authors.affiliation: Vim Spectrum, Sos. Sighisoarei 409, Corunca, Romania.
authors.forename: László
authors.initials: L
authors.lastname: Gagyi
authors.affiliation: Vim Spectrum, Sos. Sighisoarei 409, Corunca, Romania.
authors.forename: Erika Lilla
authors.initials: EL
authors.lastname: Kis
authors.affiliation: Department of Pharmaceutical Industry and Biotechnology, Faculty of Pharmacy, University of Medicine and Pharmacy of Tîrgu Mureş, Gheorghe Marinescu 38, Tîrgu Mureş RO-540139, Romania.
authors.forename: Emese
authors.initials: E
authors.lastname: Sipos
mesh_terms: D000959:Antihypertensive Agents / Q000032:analysis; D002082:Butylamines / Q000032:analysis*; D002853:Chromatography, Liquid / Q000295:instrumentation / Q000379:methods*; D004340:Drug Contamination; D020913:Perindopril / Q000032:analysis*; D013607:Tablets / Q000032:analysis
chemical_list: D000959:Antihypertensive Agents; D002082:Butylamines; D013607:Tablets; C025397:tert-butylamine; D020913:Perindopril