摘要
目的:PD12890原料药含量测定方法的建立。方法:采用高效液相色谱法,色谱柱:Agilent ZORBAX SB-C18(4.6×150mm,5μm);流动相:乙腈-甲醇-水(20:50:30);检测波长293nm;柱温:30℃;流速为1.0ml/min。结果:PD12890在0.385-0.660mg/mL范围内峰面积有良好的线性关系,r=0.9998;高、中、低浓度的平均回收率分别为99.4%,99.6%和99.8%,RSD分别为0.3%,0.2%和0.3%。结论:所用方法简单快速,专属性强,重现性好,可用于PD12890原料药的含量测定。
Objective： To establish the method for the measurement of content in PD12890 by High Performance liquid chromatography （HPLC）. Methods： With the HPLC method, the chromatographic column was applied Agilent ZORBAX SB-C18 （4.6＆#237;150mm,5μm）; the mobile phase was applied acetonitrile, methanol and water （20：50：30）; the flow rate was 1.0 mL/min; and the detected wavelength was 293 nm, the column temperature was 30℃. Results： The data showed a good linear relationship between peak area and concentration of PD12890 within 0.385-0.660 mg/mL, r=0.9998. The three concentration average recoveries were 99.4%, 99.6% and 99.8%, the RSD were 0.3%, 0.2% and 0.3%, respectively. Conclusion：The HPLC method was simple, rapid, and with strong specificity and good reproducibility which can be applied in content determination for PD12890.
出处
《科技视界》
2014年第8期12-13,共2页
Science & Technology Vision
