摘要
建立乙醇沉淀处理和HPLC测定交联透明质酸钠凝胶中盐酸利多卡因含量的方法。样品用无水乙醇处理后,分析采用XDB-C18色谱柱（4.6 mm×150 mm,5μm）,流动相为磷酸盐缓冲液-乙腈（50∶50）,用磷酸调节至p H 8.0,检测波长为254 nm,进样量为20μL。测得3批交联透明质酸钠凝胶的盐酸利多卡因含量分别为96.5%、95.5%、96.6%,平均含量为96.2%,RSD为0.6%。采用HPLC法测定交联透明质酸钠凝胶中盐酸利多卡因含量的方法具有快速、准确的优点,乙醇沉淀法较酶水解法操作更简便、成本更低,可广泛用于该产品的质量控制。
A method for determination of lidocaine hydrochloride in crosslinked sodium hyaluronate gel by alcohol deposition and HPLC detection was established.The samples were treated with anhydrous ethanol,analyzed with chromatographic conditions Agilent Eclipse XDB-C18（ 4. 6 mm×150 mm,5 μm）,mobile phase phosphate buffer（ 1 mol/L sodium dihydrogen phosphate solution 1. 3 mL and 0. 5 mol/L disodium hydrogen phosphate solution 32. 5 mL in a 1 000 m L flask were diluted with water to the scale,pH 8. 0）-acetonitrile（ 50 ∶50）,and detected at wavelength of 254 nm,with sample loading 20 μL.The contents of lidocaine hydrochloride in three batches of crosslinked sodium hyaluronate gel were tested at the level of 96. 5%,95. 5% and 96. 6%,respectively,with the average content is 96. 2% and RSD 0. 6%.The method in this article is rapid and accurate.Ethanol precipitation method is simpler and lower cost than enzyme hydrolysis and can be widely used for quality control of this product.
作者
许乐幸
姚晓敏
张佳佳
XU Le-xing;YAO Xiao-min;ZHANG Jia-jia(Zhejiang Pharmaceutical College, Ningbo 315100, China)
出处
《化学试剂》
CAS
北大核心
2018年第6期560-562,共3页
Chemical Reagents
关键词
HPLC
乙醇沉淀
盐酸利多卡因
交联透明质酸钠凝胶
HPLC
ethanol precipitation
lidocaine hydrochloride
crosslinked sodium hyaluronate gel
