中国药房2013，Vol.24Issue(25)：2369-2372,4.DOI:10.6039/j.issn.1001-0408.2013.25.24
HPLC法同时测定苯磺酸氨氯地平原料药及片剂中8种已知有关物质的含量
Determination of 8 Known Related Substances in Crude Drug and Tablet of Amlodipine Bensylate by HPLC
王全洪 1吴丹 1王玉和1
作者信息
- 1. 遵义医学院附属医院药剂科,贵州遵义563099
- 折叠
摘要
Abstract
OBJECTIVE:To establish a method for the simultaneous determination of 8 known related substances (impurity A-H) in crude drug and tablet of amlodipine besylate.METHODS:HPLC method was adopted.The determination was performed on Agilent Eclipse XDB-C18 column with 0.05 mol/L NaH2PO4-methanol (90 ∶ 10,pH 3.0) as mobile phase A and 0.02 mol/L NaH2PO4-methanol (10∶90) as mobile phase B (gradient elution) at the flow rate of 1.0 ml/min.The detection wavelength was set at 237 nm,and the column temperature was 30 ℃.RESULTS:The linear ranges of main component and 8 related substances were 0.5-15 μg/ml(r＞0.999).The detection limits were 0.5-3.2 ng/ml.The quantitation limits were 2.0-6.6 ng/ml.RSD of precision test was lower than 0.5％.Related substance of manufacturers mainly were impurity C,D and H,and the contents of impurity in the tablet were similar to those in the crude drug.CONCLUSIONS:This method is reproducible and sensitive,and can be used for the quality control of crude drug and tablet of amlodipine besylate.关键词
苯磺酸氨氯地平/片剂/原料药/有关物质/高效液相色谱法/含量测定Key words
Amlodipine besylate/ Tablet/ Crude drug/ Related substances/ HPLC/ Content determination分类
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王全洪,吴丹,王玉和..HPLC法同时测定苯磺酸氨氯地平原料药及片剂中8种已知有关物质的含量[J].中国药房,2013,24(25):2369-2372,4.
