摘要
目的建立测定愈创甘油醚原料药有关物质的高效液相色谱法。方法色谱柱为Agilent ZORBAX SB C_(18)柱(250 mm×4.6 mm,5μm),流动相为水-乙腈(梯度洗脱),流速为1.0 mL·min^(-1),检测波长为273 nm,柱温为30℃,进样量为10μL。结果愈创甘油醚峰与其杂质峰均能良好分离。杂质A、杂质B、杂质C和杂质D的各质量浓度与峰面积的线性关系良好(r≥0.9997),平均加样回收率分别为98.29%、101.35%、101.81%、101.05%,RSD值分别为1.02%、0.65%、2.83%、0.90%(n=9)。结论该方法专属性强、准确度高,可用于愈创甘油醚原料药有关物质的测定,为国内愈创甘油醚原料药质量的提升提供技术支撑。
Objective To establish an HPLC method for the determination of related substances in guaifenesin active pharmaceutical ingredient(API).Methods The chromatographic column was Agilent ZORBAX SB C_(18)(250 mm×4.6 mm,5μm),and the mobile phase was water-acetonitrile(gradient elution).The flow rate was 1.0 mL·min^(-1),the detection wavelength was 273 nm,the column temperature was 30℃,and the injection volume was 10μL.Results The peaks of guaifenesin and its impurities were well separated.The linear relationships between the mass concentrations and peak areas of impurities A,B,C,and D were good(r≥0.9997),and the average recoveries(n=9)were 98.29%,101.35%,101.81%and 101.05%,and the RSDs were 1.02%,0.65%,2.83%and 0.90%,respectively.Conclusion The method is specific and accurate,and could be used for the determination of related substances in guaifenesin API,providing technical support for the improvement of the quality of guaifenesin API in China.
作者
蔡锦雄
刘敏
李玉兰
CAI Jinxiong;LIU Min;LI Yulan(Shenzhen Institute for Drug Control,Shenzhen Key Laboratory of Drug Quality Standard Research,NMPA Key Laboratory for Bioequivalence Research of Generic Drug Evaluation,Shenzhen 518057,China)
出处
《西北药学杂志》
CAS
2024年第3期28-32,共5页
Northwest Pharmaceutical Journal
基金
国家药典委员会国家药品标准提高项目(编号:药典综[2019]35号)。
