兰索拉唑肠溶片有关物质测定方法比较

A Comparison Research on Determining Method for Substance concerned with Lansoprazole Enteric-coated Tablets

目的比较研究测定兰索拉唑肠溶片有关物质的两种标准测定方法。方法这两种方法分别收载于中国药典2010年版增补本和英国药典(BP2010)。两种方法均使用高效液相色谱法(HPLC),色谱柱分别为Kromasil C_(18)(250 mm×4.6 mm,5μm)和ECOSIL C_(18)(250mm×4.6 mm5μm),流动相分别为甲醇-水-三乙胺-磷酸溶液和乙腈-水-三乙胺-磷酸溶液。结果英国药典中的高效液相色谱法测定兰索拉唑肠溶片有关物质优于中国药典标准。结论建议测定兰索拉唑肠溶片有关物质时推广使用英国药典中的高效液相色谱法。

Object： To estimate two standard testing methods for substance concerned with lansoprazole enteric -coated tablets. Meth- ods： The relative substance are determined with the standard testing methods registered in Chinese pharmacopoeia supplement（2010） and British pharmacopoeia（BP2010） respectively. Both methods use high performance liquid chromatography （HPLC） method. The chromatographic columns are C18（250 mm×4.6 mm,5μm） and ECOSIL C18（250mm×4.6 mm5μm）,. The mobil phases are aceto- nitrile- water- triethylamine- phosphoric acid and methanal -water- triethylamine- phosphoric acid. Results： The method of British pharmacopoeia is the best one. Conclusion： We suggest that the widely used method is that of British pharmacopoeia for deter- mining substance concerned with lansoprazole enteric -coated tablets.