摘要
目的:采用HPLC法对右旋布洛芬原料及其缓释片中的有关物质进行研究。方法:α-甲基-4-丁基苯乙酸、左旋布洛芬和其他有关物质均采用HPLC法进行检测,α-甲基-4-丁基苯乙酸和其他有关物质采用Agilent Eclipse XDB-C_(18)色谱柱(150mm×4.6 mm,5μm),左旋布洛芬采用Kromasil 5-TBB色谱柱(250 mm×4.6 mm,5μm);流动相分别为乙腈-磷酸溶液(45∶55,用磷酸调节水相pH至2.5)、正己烷-叔丁基甲醚-醋酸(850∶150∶1)和乙腈-醋酸钠缓冲液(60∶40,称取醋酸钠6.13 g,加水750 ml,用冰醋酸调pH至2.5);检测波长分别为214,220和263 nm;测定α-甲基-4-丁基苯乙酸和其他有关物质时流速为1.0 ml·min^(-1),测定左旋布洛芬流速为2.0 ml·min^(-1);柱温和进样量均为30℃和20μl。结果:以上方法均能有效控制α-甲基-4-丁基苯乙酸和左旋布洛芬含量,并能有效分离和检测右旋布洛芬原料及缓释片中的其他有关物质。结论:该法专属性好,操作简便,可用于右旋布洛芬及其缓释片的有关物质的测定及质量控制。
Objective： To determine the related substances in dexibuprofen and its sustained release tablets by HPLC. Methods： The related substances including a-methyl-d-butyl benzene acetic acid, L-ibuprofen and the others Were detected by HPLC. An Agilent Eclipse XDB-C18 column （150 mm ×4.6 mm, 5 μm） was used for a-methyl-d-butyl benzene acetic acid and the other related sub- stances. A Kromasil 5-TBB column （250 mm × 4.6 mm, 5 μm） was used for L-ibuprofen. The mobile phases was acetonitrile and phosphate solution （45：55, pH value was adjusted to 2.5 by phosphoric acid）, hexane-tert-butyl ether-acetic acid （850 ： 150 ： 1 ）, acetonitrite and sodium acetate buffer （60：40, 6.13g sodium acetate was dissolved in 750ml water, and pH was adjusted to 2.5 by glacial acetic acid）, respectively. The detection wavelength was 214 rim, 220 nm and 263 rim, respectively. The flow rate for a-meth- yl-4-butyl benzene acetic acid and the other related substances was 1.0 ml · min- 1. The flow rate for L-ibuprofen was 2.0 ml · min- 1. The column temperature was 30℃ and the injection volume was 20 μ1. Results： The method could effectively detect the contents of a- methyl-d-butyl-phenylacetic acid and L-ibuprofen, and identify and separate the related substances in dexibuprofen raw material and its sustained release tablets. Conclusion： The method is specific, accurate and easy to operate, which can be used for the quality control of ibuprofen raw material and its sustained release tablets.
出处
《中国药师》
CAS
2016年第6期1088-1093,共6页
China Pharmacist
