摘要
目的建立帕米膦酸二钠中β-丙氨酸的检测方法。方法采用高效液相色谱法,以Kromasil C18（250mm×4.6 mm,5μm）为色谱柱,以甲醇-0.01 mol/L磷酸二氢钾缓冲液（用氢氧化钠调节pH值至7.0）（体积比30∶70）为流动相,流速为1.0 mL/min,检测波长为360 nm。结果β-丙氨酸的质量浓度在3-18μg/mL范围内与峰面积呈较好的线性关系,回归方程为y=0.0445x＋0.2010,r=0.998 6;平均回收率为99.1%,RSD=1.9%。结论该法简便、灵敏度高,可用于帕米膦酸二钠中β-丙氨酸的质量控制。
Objective To establish an HPLC method for analyzing β-alanine impurity in the product of pamidronate disodium. Methods Samples were analyzed on a Kromasil CIS column （250 mm ×4.6 mm,5 μm） using methanol-0.01 mol/L potassium dihydrogen phosphate solution （adjust pH to 7.0 with sodium hydroxide solution） （30：70） as mobile phase. The flow rate was 1. 0 mL/min and the detection wavelength 360 nm. Results β-alanine showed a good linearity in the range of 3-18 μg/mL and the regression equation was as following： y =0. 0445x ＋ 0. 2010（r = 0. 998 6）. The average recovery was 99. 1% with RSD of 1.9%. Conclusion The method is convenient, reliable and sensitive for the quality control of the raw material of pamidronate disodium.
出处
《广东药学院学报》
CAS
2009年第1期46-48,共3页
Academic Journal of Guangdong College of Pharmacy
基金
广东省科技计划项目(2008B030301360)
