Salas S, Talero B, Rabasco A M, González-Rodríguez M L
Department of Pharmaceutical Technology, University of Seville, C/Prof. García González 2, 41012 Seville, Spain.
J Pharm Biomed Anal. 2008 Jul 15;47(3):501-7. doi: 10.1016/j.jpba.2008.01.045. Epub 2008 Feb 9.
A simple, fast and reliable reverse-phase high-performance liquid chromatographic (HPLC) method was developed for the assay of lidocaine hydrochloride (LH) in Gantrez-alginate microspheres. Separation was achieved in a LiChrospher C18 column, using a mobile phase consisting of acetonitrile:ammonium acetate (0.0257 M) adjusted to pH 4.85 with acetic acid, in the ratio 70:30 (v/v) and a flow rate of 0.6 mL/min. The detection was made with a diode array detector measuring at the maximum for the compound. The validation study demonstrated that the method was precise, accurate and linear over the concentration range of analysis with a limit of detection of 0.001 mg/mL. The limit of quantification was 0.002 mg/mL. Linear regression analysis in the range of 0.8-2.4 mg/mL gave correlation coefficients higher than 0.995. The method developed was applied to the analysis of lidocaine in microsphere samples in order to evaluate in next papers, the encapsulation efficiency of different formulations.
建立了一种简单、快速且可靠的反相高效液相色谱（HPLC）法，用于测定甘膦-海藻酸盐微球中盐酸利多卡因（LH）的含量。在LiChrospher C18柱上进行分离，流动相由乙腈：醋酸铵（0.0257 M）组成，用醋酸调节pH至4.85，比例为70:30（v/v），流速为0.6 mL/min。使用二极管阵列检测器在化合物的最大吸收波长处进行检测。验证研究表明，该方法在分析浓度范围内精确、准确且呈线性，检测限为0.001 mg/mL，定量限为0.002 mg/mL。在0.8 - 2.4 mg/mL范围内进行线性回归分析，相关系数高于0.995。所建立的方法应用于微球样品中利多卡因的分析，以便在后续论文中评估不同制剂的包封效率。
