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HPLC法测定盐酸马尼地平片中主药的含量
引用本文:兰为民,徐炳欣,安卫平,王又新. HPLC法测定盐酸马尼地平片中主药的含量[J]. 中国药房, 2011, 0(29): 2767-2768
作者姓名:兰为民  徐炳欣  安卫平  王又新
作者单位:河南许昌市中心医院;河南许昌市药品检验所;
摘    要:目的:建立测定盐酸马尼地平片中主药含量的方法。方法:采用高效液相色谱法。色谱柱为Hypersil BDS C18,流动相为乙腈-0.04mo·lL-1K2HPO4(35∶65,V/V);流速为1.0mL·min-1;检测波长为228nm;柱温为室温;进样量为20μL。结果:盐酸马尼地平检测浓度线性范围为0.05~0.30mg·mL-1(r=0.9994,n=6);平均加样回收率为99.62%,RSD=0.84%。结论:所建立的方法简便、快速、准确、重复性好,可为建立该制剂的质量标准提供依据。

关 键 词:盐酸马尼地平片  高效液相色谱法  含量测定

Content Determination of Main Components of Manidipine Hydrochloride Tablets by HPLC
LAN Wei-min,XU Bing-xin,AN Wei-ping WANG You-xin. Content Determination of Main Components of Manidipine Hydrochloride Tablets by HPLC[J]. China Pharmacy, 2011, 0(29): 2767-2768
Authors:LAN Wei-min  XU Bing-xin  AN Wei-ping WANG You-xin
Affiliation:LAN Wei-min, XU Bing-xin, AN Wei-ping(Xuchang Municipal Central Hospital of He'nan Province, Xuchang 461000, China) WANG You-xin(Xuchang Institute for Drug Control of He'nan Province, Xuchang 461000, China)
Abstract:OBJECTIVE: To establish a method for the content determination of main components in Manidipine hydrochloride tablets. METHODS:HPLC method was adopted. The determination was performed on Hypersil BDS C18 column with mobile phase consisted of acetonitrile-0.04 mol.L-1 K2HPO4 (35:65, V/V) at the flow rate of 1.0 mL-min-1. The detected wavelength was set at 228 nm, the column temperature was room temperature, and the injection volume was 20 μL. RESULTS:The linear range of mani- dipine hydrochloride was 0.05-0.30 mg.mL-1(r=0.999 4, n=6)with an average recovery of 99.62% (RSD--0.84%). CONCLUSION: The method is simple, accurate, rapid and reproducible. It provides reference for quality standard of Manidipine hydrochlo- ride tablets.
Keywords:Manidipine hydrochloride tablet  HPLC  Content determination  
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