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盐酸利多卡因及盐酸利多卡因肾上腺素注射液的稳定性指示高效液相色谱分析

Stability-indicating high-performance liquid chromatographic analysis of lidocaine hydrochloride and lidocaine hydrochloride with epinephrine injectable solutions.

作者信息

Waraszkiewicz S M, Milano E A, DiRubio R

出版信息

J Pharm Sci. 1981 Nov;70(11):1215-8. doi: 10.1002/jps.2600701109.

DOI:10.1002/jps.2600701109
PMID:7299666
Abstract

A reversed-phase, high-performance liquid chromatographic (HPLC) procedure, which is specific and quantitative for lidocaine hydrochloride, epinephrine, and methylparaben, was developed for the analysis of lidocaine hydrochloride and lidocaine hydrochloride with epinephrine solutions for injection. Epinephrine sulfonic acid and adrenochrome are separated in this system. Also separated are lidocaine and methylparaben and their respective degradation products, 2-6-xylidine and p-hydroxybenzoic acid. The analysis requires that three detectors (two UV and one electrochemical) be connected in series. By using this arrangement, lidocaine hydrochloride and methylparaben are quantitated by UV at 254 and 280 nm, respectively, while epinephrine is quantitated electrochemically. The method is simple, accurate, precise, and rapid. No sample preparation or internal standard is necessary, and only a 2-microliter sample volume is required for analysis. Chromatographic conditions include a mu Bondapak CN column and a mobile phase of 0.01 M 1-octanesulfonic acid sodium salt, 0.1 mM edetate disodium, 2% acetic acid, 2% acetonitrile, and 1% methanol in water.

摘要

开发了一种反相高效液相色谱(HPLC)方法,用于分析盐酸利多卡因注射液以及盐酸利多卡因与肾上腺素混合注射液,该方法对盐酸利多卡因、肾上腺素和对羟基苯甲酸甲酯具有特异性且可定量。在该系统中,肾上腺素磺酸和肾上腺色素得以分离。同时分离的还有利多卡因和对羟基苯甲酸甲酯及其各自的降解产物2,6-二甲基苯胺和对羟基苯甲酸。该分析需要串联连接三个检测器(两个紫外检测器和一个电化学检测器)。通过这种设置,盐酸利多卡因和对羟基苯甲酸甲酯分别在254和280nm处通过紫外检测进行定量,而肾上腺素则通过电化学检测进行定量。该方法简便、准确、精密且快速。无需样品制备或内标,分析仅需2微升样品体积。色谱条件包括μ Bondapak CN柱和由0.01M辛烷磺酸钠、0.1mM乙二胺四乙酸二钠、2%乙酸、2%乙腈和1%甲醇组成的水相流动相。

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