摘要
目的建立2,4-二硝基氟苯柱前衍生化HPLC法测定阿仑膦酸钠片的含量。方法碱性条件下供试品与2,4-二硝基氟苯进行衍生化反应,采用Ultimate XB-C18柱,流动相为乙腈-0.01mol·L^-1 KH2PO4溶液（用三乙胺调节pH值至7.0）,梯度洗脱,流速为1.0mL.min^-1,检测波长为365nm。结果阿仑膦酸钠质量浓度在0.05～1.00mg·mL^-1范围内与峰面积呈良好线性关系（r=0.9996）,平均回收率为99.8%（n=9）。结论该方法专属性好,准确、灵敏,适合用于阿仑膦酸钠片的含量测定。
Objective To develop a HPLC method with pre-column derivatization for the determination of alendronate sodium tablets.Method Alendronate sodium was derivatized with 2,4-dinitrofluorobenin,and the analytical column was Ultimate XB-C18.The mobile phase was consisted of acetonitrile and 0.01 mol·L^-1potassium dihydrogen phosphate solution （pH adjusted to 7.0 with triethylamine）. The flow rate was 1.0 mL·min-1. The detection wavelength was 365 nm.Results The linear range was 0.05-1.00 mg· mL-1（r=0.999 6）with the average recovery of 99.8%（n=9）.Conclusion The method is simple,accurate,sensitive and suitable for the determination of alendronate sodium tablets.
出处
《广东药学院学报》
CAS
2010年第4期369-372,共4页
Academic Journal of Guangdong College of Pharmacy
基金
广东省药品监管科技支撑计划项目(SXTYJ200804)
