Determination of Main Components and Related Substances in Phenzolzine Capsules by HPLC
- VernacularTitle:HPLC法测定苯唑嗪胶囊中主成分及有关物质的含量
- Author:
Yinghua ZHANG
1
;
Jia GAO
2
;
Renping CHEN
2
;
Wei LIU
2
;
Qing WANG
2
;
Weiyu ZHANG
1
Author Information
1. School of Pharmaceutical Sciences,Changchun University of TCM,Changchun 130117,China
2. Basic Institute of TCM,Jilin Provincial Academy of TCM,Changchun 130012,China
- Publication Type:Journal Article
- Keywords:
Phenzolzine capsules;
HPLC;
Content determination;
Related substances
- From:
China Pharmacy
2019;30(19):2613-2617
- CountryChina
- Language:Chinese
-
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.