HPLC法测定盐酸奥布卡因凝胶含量及有关物质  

Determination of Content and Related Substances in Oxybuprocaine Hydrochloride Gels by HPLC

作　　者：岳青阳[1] 张迪[1] 张丽[1] 于大海[1] 孙苓苓[1] 

机构地区：[1]辽宁省食品药品检验所,沈阳110023

出　　处：《中国药师》2013年第4期577-579,共3页China Pharmacist

摘　　要：目的:建立测定盐酸奥布卡因凝胶含量及其有关物质的高效液相色谱法。方法:采用Agilent C18色谱柱(200 mm×4.6 mm,5μm),以乙腈-pH 2.5缓冲液(6 ml高氯酸、12 ml磷酸加950 ml水,用5 mol.L-1氢氧化钠调pH至2.5,用水稀释至1 000 ml)(30∶70)为流动相,流速为1.0 ml.min-1,检测波长为309 nm,柱温30℃。结果:盐酸奥布卡因与其相邻杂质峰能完全分离,在7.811～234.33μg.ml-1范围内与峰面积线性关系良好(r=1.000 0),平均回收率为101.3%(RSD=0.7%,n=9);最低检出量为0.3 ng。结论:本法专属性强,准确可靠,可用于盐酸奥布卡因凝胶的质量控制。Objective： To establish an HPLC method for the determination of oxybuprocaine hydrochloride gels and the related substances. Method： The determination was performed by HPLC with an Agilent C18 column（200 mm×4.6 mm,5μm）. The mobile phase was acetonitrile-pH 2.5 buffer solution （ adding 6ml perchloric acid and 12 ml phosphoric acid into 950 ml water, adjusting pH to 2.5 by 5 ml.L^-1 sodium hydroxide and diluting to 1 000 ml with water） （30： 70） with a flow rate of 1.0 ml.min^-1 , and the UV detection wavelength was 309 nm. Result： Oxybuprocaine hydrochloride could be completely separated from the other impurities. The linear range was 7.811-234.33 μg.ml^-1 （ r = 1. 000 0） , and the average recovery was 101.3% （RSD = 0.7% , n = 9）. The detection limit was O. 3 ng. Conclusion： The method is specific and accurate, and suitable for the quality control of oxyhuprocaine hydrochloride gels.

关 键 词：盐酸奥布卡因凝胶 含量测定 有关物质 

分 类 号：R927.2[医药卫生—药学]