反相高效液相色谱法测定比索洛尔氢氯噻嗪片的有关物质

目的建立RP-HPLC法同时测定比索洛尔氢氯噻嗪片中2个主成分的有关物质。方法色谱柱为AgilentXDB-C18（4.6 mm×250 mm,5μm）,流动相为0.06 mol.L-1NaH2PO4和0.002 5 mol.L-1辛烷磺酸钠水溶液（用磷酸调pH至3.50）-乙睛（75：25）,柱温35℃,检测波长为223 nm。外标法计算4-氨基-6-氯-1,3-苯二磺酰胺的含量,自身对照法计算其他2个主成分的有关物质的含量。结果在该色谱条件下,2个主成分与其有关物质以及有关物质之间能较好分离,主要杂质得以甄别和归属,并对2个主要降解产物进行了结构分析。结论该方法简便、准确、专属性好,可用于比索洛尔氢氯噻嗪片中有关物质的质量控制。

RP-HPLC determination of related substances in bisoprolol fumarate and hydrochlorothiazide tablets

Objective To develop an RP-HPLC method for simultaneous determination of 2 main components and related substances in compound tablets of bisoprolol fumarate and hydrochlorothiazide tablets.Methods An Agilent XDB-C18 column（4.6 mm×250 mm,5 μm） and 0.06 mol·L-1NaH2PO4 and 0.002 5 mol·L-1 octane sulfonate aqueous solution（pH=3.50,adjusted with phosphoric acid）-acetonitrile（75 ： 25） as the mobile phase were used for the chromatography separation.The column temperature was 35 ℃ and the detection wavelength was 223 nm.We determined 4-amino-6-chloro-1,3-benzenedisulfonamide with the external standard method while the other 2 main components and their related substances were determined by self-control method.Results In the chromatographic conditions,the impurity peaks were completely separated,the main degradation impurities were attributed and related substances from degradation were determined.Conclusion This method is simple,accurate,specific and practicable for the determination of the content and related substances in the tablets.