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目的建立HPLC法测定止痒灵搽剂质量控制方法。方法采用HPLC法,Agilent ZORBAXSB-C18色谱柱,0.5%三乙胺-乙腈(50∶50)为流动相,流速为1.0ml·min~(-1),检测波长为258nm,对处方中的盐酸苯海拉明含量进行定量测定。结果定量分析中盐酸苯海拉明保留时间为7.5min,在0.05~0.50mg·ml~(-1)(r=0.9999)范围内与峰面积呈良好线性关系,盐酸苯海拉明平均回收率为100.18%,RSD为0.29%(n=9)。结论本方法准确、可靠、专属性强,可用于止痒灵搽剂的质量控制。
Objective To establish a HPLC method for the determination of antipruritic liniment quality control methods. Methods The HPLC method was applied on an Agilent ZORBAXSB-C18 column with a mobile phase of 0.5% triethylamine-acetonitrile (50:50) at a flow rate of 1.0 ml · min -1 and a detection wavelength of 258 nm. Diphenhydramine content quantitative determination. Results The retention time of diphenhydramine hydrochloride in the quantitative analysis was 7.5 min. The linear range was within the range of 0.05-0.50 mg · ml -1 (r = 0.9999). The average recoveries of diphenhydramine hydrochloride Was 100.18% with a RSD of 0.29% (n = 9). Conclusion The method is accurate, reliable and specific. It can be used for the quality control of antipruritic lotion.