摘要
目的：建立清洁验证中残留物非诺贝特含量测定的高效液相色谱法。方法：色谱柱为Agilent ZORBAX SB-C18（150 mm×4.6 mm,5μm）,流动相为水（磷酸调节p H至2.5）-乙腈（30∶70）,检测波长：286 nm,流速：1.0 m L/min,柱温：25℃,进样量：20μL。结果：非诺贝特在0.09-0.90μg/m L范围内线性关系良好,r2=0.999 4;回收率：99.69%,RSD=0.16%（n=9）。结论：该法操作简便、结果准确,可以用于清洁验证残留物非诺贝特的定量分析。
Objective：To establish a method for the content determination of fenofibrate residues in the cleaning validation of fenofibrate sustained-release tablets by HPLC. Methods： Separation was carried out using Agilent ZOR- BAX SB-C18 （ 150 mm× 4.6 ram, 5 μm） column with phosphoric acid solution （pH = 2.5 ）-acetonitrile （30：70） as the mobile phase, the detection wavelength was at 286 nm, the flow was 1.0 mL/min and the column temperature was at 25 ℃ with sample size of 20 txL. Results： The linear range of fenofibrate concentration was from 0.09 to 0.90 μg/mL and the correlation coefficient was 0.999 4. The average recovery of samples was 99.69% and RSD was 0.16%（n = 9）. Conclusion： This method is convenient and accurate without interference and is suitable for the quantitative determination of fenofibrate residues in the cleaning validation of fenofibrate sustained-release tablets.
出处
《中国执业药师》
CAS
2015年第8期28-31,共4页
China Licensed Pharmacist
作者简介
洪丽萍，女，药师。研究方向：药物分析和标准研究。E—mail：hongliping@yangzijiang．com
