Determination of Content and Related Substances of Amlodipine Besylate Tablets by HPLC
- VernacularTitle:HPLC法测定苯磺酸氨氯地平片的含量及其有关物质
- Author:
Li WANG
;
Lanhui SHEN
- Publication Type:Journal Article
- Keywords:
HPLC;
HPLC-QTOF MS;
Amlodipine besylate tablets;
Related substances
- From:
China Pharmacist
2014;(12):2046-2050
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish an HPLC method compatible with the mass spectrometry for the determination of the content and related substances in amlodipine besylate tablets. Methods:The sample was separated on a CAPCELL PAK C18 column (250 mm × 4. 6 mm, 5 μm) with the mobile phase consisting of methanol and 20 mmol·L-1 ammonium acetate (60∶40) at a flow rate of 1. 0 ml·min-1 . The detection wavelength was set at 237 nm. The column temperature was 35℃ and the injection volume was 20 μl. Be-sides, an HPLC-QTOF MS method was used to identify the molecular structure of the related substances of amlodipine. Results: The related substances were completely separated from amlodipine. The linear range of amlodipine besylate was 10-100 μg · ml-1 ( r =0. 999 8), and the mean recovery was 99. 2%(RSD=1. 0%,n=9). The main related substances could be detected by HPLC-QTOF MS. Conclusion:The established method is accurate, reliable and reproducible, which can be used in the quality control of amlodip-ine besylate tablets.
