Determination of Content and Related Substances of Amlodipine Besylate Tablets by HPLC / 中国药师
China Pharmacist
;
(12): 2046-2050, 2014.
Artículo
en Chino
| WPRIM
| ID: wpr-458785
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.
Texto completo:
Disponible
Índice:
WPRIM (Pacífico Occidental)
Idioma:
Chino
Revista:
China Pharmacist
Año:
2014
Tipo del documento:
Artículo
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