HPLC法测定吡格列酮二甲双胍片中盐酸吡格列酮的有关物质

HPLC method for determinnation of the related substances of Pioglitazone hydrochloride of Pioglitazone Metformin Tablets

摘要：目的：建立吡格列酮二甲双胍片中盐酸吡格列酮有关物质的高效液相色谱方法。方法：采用为依利特c18色谱柱（250×4．6mm，5um）；以水-乙腈-乙酸=550：450：1．2（用氨试液调节pH值至5．8）作为流动相；检测波长为225nm。结果：三批样品（BE1101、BE1102、BE1103）盐酸吡格列酮单个杂质（％）分别为0．15、0．14、0．14；有关物质（％）分别为0．22、0．21、0．21。结论：采用HPLC法测定盐酸吡格列酮有关物质方法简便，结果准确可靠，二甲双胍无干扰。

Purpose： To establish an RP- HPLC method for determinnation of the related substances of Pioglitazone hydrochloride of Pioglitazone Metformin Tablets . Methods： The separation was performed on an Elite C18 column （250 × 4.6 mm, 5 um）; and the mobile phase consisted of water - acetonitrile - acetic acid = 550：450：1.2 （ammonia solution adjusted to pH 5.8）.The detection was set at 225nm. Results： The three batches of samples （BE1101,BE1102,BE1103） hydrochloride pioglitazone single impurity （%） were 0.15,0.14,0.14; related substances （%） were 0.22,0.21,0.21. Conclusion： the method for determination of pi- oglitazone hydrochloride related substances method is simple, accurate and reliable, metformin no interference.