HPLC法测定贝那普利氢氯噻嗪片的有关物质

Determination of related substances in Benazepril Hydrochloride and Hydrochlorothiazide Tablets by HPLC

目的建立高效液相色谱法测定贝那普利氢氯噻嗪片的有关物质。方法采用Ultimate AQ-C18色谱柱（250mm×4.60mm,5μm）;流动相：四氢呋喃-水-冰醋酸（250mL＋750mL＋4mL,加入四丁基溴化铵1.0g）;流速：1.5mL·min-1;检测波长：240和316nm。结果杂质CGS14831的线性范围为3.74~28.08μg·mL-1,相关系数r=0.999 6;杂质CGP42454A、CGS 14829A的线性范围为1.63~12.19μg·mL-1：相关系数r=0.999 5;杂质SU5683的线性范围为2.03~15.24μg·mL-1,相关系数r=0.999 7。结论该方法重复性好,结果准确,能更好地控制贝那普利氢氯噻嗪片中有关物质的含量。

Objective To establish a headspace capillary GC method for the determination of the residual solvents in ornidazole . Methods An Agilent DB‐624 capillary column（30 m × 0 .32 mm × 0 .18 μm） was used .The inlet temperature was 150 ℃ and the FID detector temperature was 250 ℃ .The oven temperature was initially held at 45 ℃ for 15 min and then programmed to 220 ℃at 40 ℃ · min-1 .The headspace sampling was used at heated temperature 85 ℃ for 30 min .Results The linear correlation coffi‐cients of this method for methanol ,ethanol ,ethyl acetate ,dichloromethane ,epichlorohydrin were between 0 .997 8‐0 .999 9 ,respec‐tively .All the average recoveries were between 100 .9%‐103 .4% ,RSDs were between 1 .4%‐3 .3% .Conclusion The method was simple ,accurate ,so it is proposed for the determination of the residual solvents in ornidazole .