Content Determination of Main Component and Related Substances in Amlodipine Maleate Dispersible Tablets by HPLC
- VernacularTitle:HPLC法测定马来酸氨氯地平分散片中主药及有关物质含量
- Author:
Yifu TAO
;
Fang QIAN
;
Sheng LOU
;
Junrong ZHU
- Publication Type:Journal Article
- Keywords:
Amlodipine maleate;
Dispersible tablets;
HPLC method;
Content determination;
Related substance
- From:
China Pharmacy
2005;0(17):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE: To established an HPLC method for the determination of main component and related substances in amlodipine maleate dispersible tablets. METHODS: The separation was performed on a Lichrospher C18 column. The mobile phase consisted of methanol-0.03 mol?L-1 potassium dihydrogen phosphate (70 ∶ 30) at the flow rate of 1 mL?min-1. The detection wavelength was set at 237 nm and column temperature was 30 ℃. RESULTS: The linear range of amlodipine maleate were 31.94～127.75 ?g?mL-1 (r=0.999 8, n=5). The average recovery was 99.5% (RSD=0.39%, n=9). The contents of related substance were all lower than 0.38%. CONCLUSION: The method is simple, rapid, accurate and specific for the quality control of amlodipine maleate dispersible tablets.
