高效液相色谱法检测盐酸羟甲唑啉滴鼻液中的有关物质.docVIP

精品论文 参考文献 高效液相色谱法检测盐酸羟甲唑啉滴鼻液中的有关物质 （黑龙江省食品药品检验检测所 黑龙江 哈尔滨 150088） 　　【摘要】 目的：建立测定盐酸羟甲唑啉滴鼻液中有关物质的高效液相色谱法。方法：采用Agilent Eclipse XDB-C18柱（4.6 mmtimes;250mm,5mu;m）,以1.36g/L磷酸二氢钾溶液（用磷酸调节pH至3.0）为流动相A，以乙腈为流动相B，检测波长220nm,柱温25℃，进样量10mu;L。结果：盐酸羟甲唑啉杂质A浓度在0.5063mu;gmiddot;mL-1～5.0629mu;gmiddot;mL-1（r=1.000，n=5）范围内线性关系良好，平均回收率为98.7%，RSD为1.8%(n = 9)。结论：本方法专属性强，简便准确，可用于盐酸羟甲唑啉滴鼻液中有关物质的检查。 　　【关键词】 高效液相色谱法；盐酸羟甲唑啉滴鼻液；有关物质 　　【中图分类号】R927.2 【文献标识码】A 【文章编号】2095-1752（2016???27-0395-02 　　Determination of Related Substances in Oxymetazoline Hydrochloride Nasal Drops by HPLC 　　Zhao Xiaodi，YU Jia，Lou Zhihong，Zhang Xiao-ning，Yang Lihong 　　Heilongjiang Institute for Drug Control，Heilongjiang Harbin 150088,China 　　【Abstract】 Objective To establish an HPLC method to analysis the related substances in Oxymetazoline Hydrochloride Nasal Drops. Methods An Agilent Eclipse XDB-C18 column（4.6 mmtimes;250 mm,5mu;m）was used for liquid chromatography. The 1.36 gmiddot;L-1 solution of potassium dihydrogen phosphate adjusted to pH3.0 with phosphoric acid was used as the mobile phase A,and acetonitrile was used as the mobile phase B. The detection wavelength was set at 220 nm, and the column temperature was 25℃. Results The concentration of impurity A in the range of 0.5063 mu;gmiddot;mL-1～5.0629 mu;gmiddot;mL-1 showed good liner relation with the peak area (r=1.000，n=5). The average recovery was 98.7%,RSD = 1.8%,(n = 9).Conclusions:The method can be used for the determination of related substances in Oxymetazoline Hydrochloride Nasal Drops which provides the advantage of specificity,simplicity and accuraty. 　　【Key words】 High Performance Liquid Chromatography（HPLC）；Oxymetazoline Hydrochloride Nasal Drops；Related Substances 　　盐酸羟甲唑啉为咪唑啉类衍生物，属肾上腺素类药物，特异兴奋alpha;肾上腺素受体，在不同组织可致血管收缩[1]。盐酸羟甲唑啉滴鼻液临床主要用于治疗急慢性鼻炎、鼻窦炎、过敏性鼻炎、肥厚性鼻炎等。现行盐酸羟甲唑啉滴鼻液质量标准中未对有关物质进行控制[2]，亦未见相关文献报道过其有关物质方面的研究。本研究在参考《欧洲药典》7.0版[3]盐酸羟甲唑啉原料药有关物质测定方法和相关文献[4-7]基础上，采用高效液相色谱法检查盐酸羟甲唑啉滴鼻液中的有关物质，经验证，本方法专属性强，简便准确，可用于盐酸羟甲唑