ABSTRACT
OBJECTIVE: To establish a method for content determination of main components and its related substances in Phenzolzine capsules. METHODS: HPLC method was adopted for content determination of main components. The contents of related substance (known impurity 1, known impurity 2, total impurity) were calculated with principle component self-control method. The determination was performed on Inertsil ODS-2 C18 column with mobile phase consisted of acetonitrile-water (55 ∶ 45, V/V)at the flow rate of 1.0 mL/min. The detection wavelength was set at 223 nm, and column temperature was 25 ℃. The sample size was 20 μL. RESULTS: The main component phenzolzine and other impurity peaks were well separated. The liner range of phenzolzine was 20.04-60.12 μg/mL (r=1.000 0). RSDs of precision, stability (24 h) and reproducibility tests were all ≤0.5% (n=6). Average recovery was 97.50% (RSD=0.36%, n=3). The detection limit and quantification limit of phenzolzine were 0.91 ng and 3.04 ng. In 3 batches of samples, average value of phenzolzine, known impurity 1, known impurity 2 and total impurity were 106.68%, 0.002 1%, 0.044 0% and 0.046 2%, respectively. CONCLUSIONS: Established method is simple, specific, sensitive and accurate for content determination of main component and related substance in Phenzolzine capsules. It is suitable for quality control of Phenzolzine capsules.