title: A validated stability-indicating ultra performance liquid chromatography method for the determination of potential process-related impurities in eplerenone.
abstract: A simple, sensitive, and accurate stability-indicating analytical method has been developed and validated using ultra high performance liquid chromatography. The developed method is used to evaluate the related substances of eplerenone (EP). The degradation behavior of EP under stress conditions was determined, and the major degradants were identified by ultra high performance liquid chromatography with tandem mass spectrometry. The chromatographic conditions were optimized using an impurity-spiked solution, and the samples, generated from forced degradation studies. The resolution of EP, its potential impurities, and its degradation products was performed on a Waters UPLC BEH C18 column (50 × 2.1 mm, 1.7 μm) by linear gradient elution using a mobile phase consisting of 10 mmol/L ammonium acetate adjusted to pH 4.5, methanol and acetonitrile. A photo-diode array detector set at 245 nm was used for detection. The flow rate was set at 0.3 mL/min. The procedure had good specificity, linearity (0.02-3.14 μg/mL), recovery (96.1-103.9%), limit of detection (0.01-0.02 μg/mL), limit of quantitation (0.03-0.05 μg/mL), and robustness. The correction factors of the process-related substances were calculated.
authors.affiliation: Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing, Jiangsu, P. R. China.
authors.forename: Mingluo
authors.initials: M
authors.lastname: Du
authors.affiliation: Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing, Jiangsu, P. R. China.
authors.forename: Chunyan
authors.initials: C
authors.lastname: Pan
authors.affiliation: Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing, Jiangsu, P. R. China.
authors.forename: Jing
authors.initials: J
authors.lastname: Chen
authors.affiliation: Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing, Jiangsu, P. R. China.
authors.forename: Min
authors.initials: M
authors.lastname: Song
authors.affiliation: Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing, Jiangsu, P. R. China.
authors.forename: Tingting
authors.initials: T
authors.lastname: Zhu
authors.affiliation: Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing, Jiangsu, P. R. China.
authors.forename: Taijun
authors.initials: T
authors.lastname: Hang
mesh_terms: D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D000077545:Eplerenone; D000451:Mineralocorticoid Receptor Antagonists / Q000032:analysis*; D008968:Molecular Conformation; D013148:Spironolactone / Q000031:analogs & derivatives* / Q000032:analysis
chemical_list: D000451:Mineralocorticoid Receptor Antagonists; D013148:Spironolactone; D000077545:Eplerenone
keywords: Eplerenone; Impurities; Ultra high performance liquid chromatography