| 高效液相色谱法测定阿仑膦酸钠片的含量 |
| |
| 引用本文： | 王晨光,高志峰,孙成勇,董新明.高效液相色谱法测定阿仑膦酸钠片的含量[J].中国医药导报,2012,9(19):113-114. |
| |
| 作者姓名： | 王晨光 高志峰 孙成勇 董新明 |
| |
| 作者单位： | 石药集团欧意药业有限公司,河北石家庄,050051 |
| |
| 基金项目： | 国家科技重大专项子课题(专项名称:重大新药创制;子课题名称:阿仑膦酸钠原料及制剂技术改造;子课题编号2011ZX09201-101-23) |
| |
| 摘 要： | 目的建立高效液相色谱法测定阿仑膦酸钠片的含量。方法色谱柱为PLRP—S100A（4．6mm×250mm，8μm），流动相为缓冲盐（取柠檬酸钠14．7g和磷酸氢二钠7．05g加水溶解并稀释至1000mL，用磷酸调节pH值为8．0）-乙腈-甲醇（75：20：5），检测波长为266nm，流速为1．0mL／min。结果阿仑膦酸的质量浓度在5．3～84．2I,zg／mL内呈良好的线性相关性，相关系数r=0．9999，平均回收率为99．65％（RSD=0．62％，n=9），含量符合规定。结论方法学研究表明本法系统适用性良好，该方法准确、可靠、简便、易行，可作为制剂的含量测定方法。
|
| 关 键 词： | 阿仑膦酸钠片 含量 高效液相色谱法 |
Content determination of Alendronate Sodium Tablets by HPLC |
| |
| WANG Chenguang
,
GAO Zhifeng
,
SUN Chengyong
,
DONG Xinming.Content determination of Alendronate Sodium Tablets by HPLC[J].China Medical Herald,2012,9(19):113-114. |
| |
| Authors: | WANG Chenguang GAO Zhifeng SUN Chengyong DONG Xinming |
| |
| Institution: | CSPC Ouyi Pharmaceutical Co.,Ltd,Hebei Province,Shijiazhuang 050051,China |
| |
| Abstract: | Objective To establish the HPLC method for the content determination of Alendronate Sodium Tablets.Methods A PLRP-S 100A(4.6 mm × 250 mm,8 μm) column was used.The mobile phase consisted of buffer(transfer 14.7 g of sodium citrate dihydrate and 7.05 g of anhydrous dibasic phosphate to 1 000 mL volumetric flask,dilute with water,and adjust pH to 8.0 with H3PO4)-acetonitrile-methanol(75∶20∶5).The detection wavelength was 266 nm.The flow rate was 1.0 mL/min.Results The linear range of alendronate was 5.3-84.2 μg/mL(r = 0.999 9).The average recovery of alendronate was 99.65%(RSD=0.62%,n = 9),the result of content of the tablets met the requirement.Conclusion The methodology study has indicated that the method has a good system suitability of accurate,simple,rapid,qualitative,which can be the method to determine the content of Alendronate Sodium Tablets. |
| |
| Keywords: | Alendronate Sodium Tablets Content HPLC |
| 本文献已被 CNKI 维普 万方数据 等数据库收录！ |
|
