摘要
目的建立测定阿洛西林钠中有关物质及其含量的高效液相色谱法。方法色谱柱为依利特Hypersil C18柱（250mm×4．6mm，5μm）；流动相为磷酸盐缓冲液（取无水磷酸氢二钾4．09g与磷酸二氢钾0．58g，加水溶解并稀释至1000mL，混匀即得）-乙a（85：15），检测波长为210nm，流速为1．0mL／min，柱温为35℃。结果建立的色谱法使阿洛西林与有关物质能完全分离，阿洛西林质量浓度在0．2～1g／L范围内与峰面积线性关系良好，相关系数r2=0．9999，平均回收率为99．2％，RSD=0．8％（n=9）。结论该方法简便、准确、专属性强，可用于阿洛西林钠的有关物质及其含量的测定。
Objective To establish a HPLC method for the determination of the related substances of azlocillin sodium and their con- tents. Mehods The Hypersil CJs co｜umn （250 mm×4.6 mm,5 μm ） was used. The mobile phase was the phosphate buffer （taking anhydrous K2HP03 4. 09 g and KH2P03 0. 58 g,adding water for dissolution and diluting to I 000 mL for mixing evenly） -acetonitrile （85 ： 15）.The UV detection wavelength was 210 nm. The flow rate was 1.0 mL/min. The temperature of the column was 35 ℃. Results The established method was proved to completely separate azlocillin sodium from its related substances. The linear range of a- zlocillin sodium was 0. 2- 1 g/L, r2 =0. 999 9 ,the mean recovery rate was 99.2%. Conclusion This method is simple and accurate with strong specificity,and suitable for the determination of the related substances of azlocillin sodium and their contents.
出处
《中国药业》
CAS
2013年第18期50-51,共2页
China Pharmaceuticals
