高效液相色谱法测定盐酸苯乙双胍的有关物质.pdfVIP

药物分析杂志Chin J Pharm Anal 2008，28(6) ．．——967．-—— 高效液相色谱法测定盐酸苯乙双胍的有关物质 王本晓，朱海燕，丁洁 (山东省医药工业研究所，济南250100) 摘要 目的：建立高效液相色谱法测定盐酸苯乙双胍的有关物质。方法：采用Phenomenex—ODS—C 色谱柱(250 mm×4．60 mm，5 m)；以甲醇一5 mmol·L 磷酸二氢钾溶液(含有10 mmol·L 十二烷基磺酸钠，用磷酸调节pH至3．5±0．05)(72： 28)为流动相；流速1．0 mL·min～；检测波长216 nm；柱温：室温。结果：盐酸苯乙双胍的线性范围为3～300 g·mL一，r： 0．9999，检测限为0．5 ng，精密度为0．4％；双氰胺的线性范围为0．05～0．3 g·mL～，r=0．9999，检测限为0．15 ng，精密度为 0．6％。结论：本方法简便可靠，灵敏度高，重现性好，可用于盐酸苯乙双胍的质量控制。 关键词：盐酸苯乙双胍；高效液相色谱法；有关物质 中图分类号：R917 文献标识码：A 文章编号：0254—1793(2008)06—0967—03 HPLC determination of the related substances of phenformin hydr0chl0ride WANG Ben—xiao，ZHU Hai—yan，DING Jie (Shandong Institute of Pharmaceutical Indust~，Jinan，2501O0) Abstract Objective：To establish an HPLC method for determination of the related substances of phenformin hydrochloride．Methods：The separation was performed on a Phenomenex—ODS—C18column(250 mm×4．60 mm， 5 Ixm)．The mobile phase was composed of methanol一10 mmol·L～sodium dodecylsufonate in 5 mmol·L～po— tassium dihydrogen phosphate(previously adjusted to pH 3．5±0．05 with phosphoric acid)(72：28)．The flow rate was 1．0 mL·rain一．The detection was canied out with a diode array detector at 216 nm．Column temperature was at room temperature．Results：The calibration curve of phenformin hydrochloride was linear between 3 to 300 Ixg· mL (r=0．9999)，the detection limit was 0．5 ng with RSD of 0．4％(n=6)；The calibration curve of dicyandia— mide was linear between 0．05—0．3 Ixg·mL (r=0．9999)，the detection limit was 0．15 ng with RSD of 0．6％ (n=6)．Conclusion：The method is simple and accurate with good sensitivity and reproducibility．It can be used for the quality control of phenformin hydrochloride． Key words：phenformin hydrochloride：HPLC：related substances