中国药房2013，Vol.24Issue(21)：2007-2009,3.DOI:10.6039/j.issn.1001-0408.2013.21.31
HPLC法测定盐酸阿莫地喹片的含量和有关物质
Content Determination of Amodiaquine Hydrochloride Tablets and Related Substances by HPLC
冯国1
作者信息
- 1. 广西壮族自治区食品药品检验所,南宁530021
- 折叠
摘要
Abstract
OBJECTIVE:To establish a method for the determination of Amodiaquine hydrochloride tablets and related substances.METHODS:HPLC method was adopted and compared with results of TLC and UV in national standard.The determination was performed on Insteril ODS-3 C18 column with mobile phase consisted of water-triethylamine-phosphoric acid (100 ∶ 1 ∶0.5)-methanol (75∶25) at the flow rate of 1.0 ml/min.The detection wavelength was set at 342 nm,and column temperature was 30 ℃.RESULTS:The linear range of amodiaquine hydrochloride was 10.06-100.55 μg/ml (r=0.999 9) with mean recovery of 99.56％ (RSD=0.87％,n=9).The limit of quantitation and detection were 6.7 and 0.4 ng.The content results by 2 methods were similar and their RSD were 0.60％ and 0.71％.No impurity was found by TLC detection,and the amount of impurity were 0.10 ％-0.13 ％ detected by HPLC.CONCLUSIONS:The method is accurate,simple and reliable for the quality control for Amodiaquine hydrochloride tablets.It can be considered to replace national standard method.关键词
盐酸阿莫地喹片/有关物质/含量测定/高效液相色谱法Key words
Amodiaquine hydrochloride tablets/ Related substances/ Content determination/ HPLC分类
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冯国..HPLC法测定盐酸阿莫地喹片的含量和有关物质[J].中国药房,2013,24(21):2007-2009,3.
