title: LC-MS/MS characterization of forced degradation products of zofenopril.
abstract: A rapid, specific and reliable isocratic LC-MS/MS method has been developed and validated for the identification and characterization of stressed degradation products of Zofenopril. Zofenopril, an anti-hypertensive drug, was subjected to hydrolysis (acidic, alkaline and neutral), oxidation, photolysis and thermal stress, as per ICH-specified conditions. The drug showed extensive degradation under oxidative and base hydrolysis stress conditions. However, it was stable to thermal, acid, neutral and photolysis stress conditions. A total of 6 degradation products were observed and the chromatographic separation of the drug and its degradation products were achieved on Phenomenex (Luna) C18 (250mm×4.6mm, i.d., 5μm) column using 20mM ammonium acetate: acetonitrile (50:50, v/v) as a mobile phase. The degradation products were characterized by LC-MS/MS and its fragmentation pathways were proposed. The LC-MS method was validated with respect to specificity, linearity, accuracy and precision. No previous reports were found in the literature regarding the degradation behavior of zofenopril.
authors.affiliation: Department of Chemistry, National Institute of Technology, Warangal, India. Electronic address: tippaniramesh.1@gmail.com.
authors.forename: Thippani
authors.initials: T
authors.lastname: Ramesh
authors.forename: Pothuraju
authors.initials: P
authors.lastname: Nageswara Rao
authors.forename: Ramisetti
authors.initials: R
authors.lastname: Nageswara Rao
mesh_terms: D000959:Antihypertensive Agents / Q000032:analysis / Q000737:chemistry; D002216:Captopril / Q000031:analogs & derivatives* / Q000032:analysis / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid; D002853:Chromatography, Liquid; D004355:Drug Stability; D006868:Hydrolysis; D057230:Limit of Detection; D018384:Oxidative Stress; D010100:Oxygen / Q000737:chemistry; D010782:Photolysis; D015203:Reproducibility of Results; D053719:Tandem Mass Spectrometry; D013696:Temperature
chemical_list: D000959:Antihypertensive Agents; C044958:zofenopril; D002216:Captopril; D010100:Oxygen
keywords: Characterization; Forced degradation; LC–MS/MS; Validation; Zofenopril