高效液相色谱法测定阿仑膦酸钠片的含量

Content determination of Alendronate Sodium Tablets by HPLC

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-S 100A(4.6 mm×250 mm,8μm),流动相为缓冲盐(取柠檬酸钠14.7 g和磷酸氢二钠7.05 g加水溶解并稀释至1 000 mL,用磷酸调节pH值为8.0)-乙腈-甲醇(75∶20∶5),检测波长为266 nm,流速为1.0 mL/min。结果阿仑膦酸的质量浓度在5.3～84.2μg/mL内呈良好的线性相关性,相关系数r=0.999 9,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。

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 HsPO4） - 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.