HPLC法测定愈创甘油醚缓释片中的有关物质

HPLC determination of related substances of guaifenesin extended release tablets

目的建立HPLC法测定愈创甘油醚缓释片中有关物质的含量,并对有关物质进行定性分析。方法测定有关物质的方法采用不加校正因子的主成分自身对照法。采用Hypersil ODS2C18色谱柱（250 mm×4.6 mm,5μm）,以水-甲醇-冰醋酸（体积比60∶40∶1.5）为流动相,流速为1.0 mL·min^-1,检测波长为272 nm。通过ESI-MS及与标准品对照对有关物质进行结构确证。结果在该色谱条件下,愈创甘油醚与其杂质分离良好,愈创甘油醚有关物质的质量在10.028~501.4 ng内有良好的线性关系,r=0.999 2;最低检出限为0.1 mg·L^-1;最低定量限为0.2 mg·L^-1。结论该方法快速、灵敏、准确实用,适用于愈创甘油醚及其有关物质的含量测定。

Objective To establish an HPLC method for determination of related substances of guaifenesin extended release tablets. Methods An Hypersil ODS2 C18 column （ 250 mm×4.6 mm,5μm ） was used in the study, the mobile phase consisted of water-methanol-acetic acid （ V： V： V = 60： 40： 1.5 ）, the flow rate was set at 1.0 mL. min ^- 1, the detection wavelength was 272 nm. Results Good resolution for guaifenesin and the related substances was obtained. There was good linear relationship with the mass range of guaifene- sin of 10. 028-501.4 ng （r =0. 999 9 ）, The limit of detection was 0. 1 mg.L^-1 and the limit of quantifica- tion was 0. 2 mg. L^-1. Conclusions The method is simple, sensitive, accurate and can be used for determina- tion of the related sunstances of guaifenesin extended release tablets.