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目的建立HPLC法测定止痒灵搽剂中盐酸苯海拉明的含量。方法采用SHISEIDO CAPCELL PAK CN色谱柱(4.6 mm×250 mm,5μm),以水-乙腈(63∶37,内含0.5%三乙胺,用冰醋酸调节p H至6.5)为流动相,检测波长:220 nm;流速:1.0 ml·min-1;柱温:30℃。结果盐酸苯海拉明在5.035~50.35μg·ml-1的范围内线性关系良好(r=1.0000),平均回收率为99.85%,RSD为0.21%(n=9)。结论本方法简便、测定结果准确,重复性好,可用于止痒灵搽剂中盐酸苯海拉明的含量测定。
Objective To establish HPLC method for determination of antipruritic liniment in the content of diphenhydramine hydrochloride. Methods SHISEIDO CAPCELL PAK CN column (4.6 mm × 250 mm, 5 μm) was used as the mobile phase with water-acetonitrile (63:37, containing 0.5% triethylamine and pH 6.5 with glacial acetic acid) : 220 nm; flow rate: 1.0 ml · min-1; column temperature: 30 ° C. Results Diphenhydramine hydrochloride showed a good linearity (r = 1.0000) in the range of 5.035-50.35μg · ml-1 with an average recovery of 99.85% and a RSD of 0.21% (n = 9). Conclusion The method is simple, accurate, reproducible and can be used to determine the content of diphenhydramine hydrochloride in Zhiyangling liniment.