高效液相色谱法测定马来酸依那普利片中依那普利的含量

IF 1 Q4 CHEMISTRY, MULTIDISCIPLINARY Ovidius University Annals of Chemistry Pub Date : 2021-01-01 DOI:10.2478/auoc-2021-0010
S. Gherman, D. Zavastin, A. Șpac, A. Panainte
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引用次数: 0

摘要

建立了测定马来酸依那普利片中依那普利含量的高效液相色谱法,并进行了验证。色谱柱为Hewlett Zorbax SB-C 18 (150 × 4.6 mm, 5 μm),流动相为乙腈:0.025 M磷酸盐缓冲液,调节pH为3 (70:30 v/v),泵送流速为0.8 mL/min, 210 nm紫外检测。根据ICH指南(线性度、检出限、定量限、精密度、准确度、回收率和系统适用性)对该方法进行了验证。总运行时间小于3 min,保留时间为2.3 min。在10 ~ 100 μg/mL范围内,校正曲线呈线性关系,相关系数r2 = 0.9998。该方法可用于测定马来酸依那普利片中依那普利的含量。该方法灵敏度高,专属性好,重复性好,操作简便,可用于中药制剂中马来酸依那普利的常规分析。
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Determination of Enalapril maleate from tablets using a new HPLC method
Abstract For the determination of enalapril maleate in tablets a new, simple and economical HPLC method was developed and fully validated. Chromatographic separation was achieved on Hewlett Zorbax SB-C 18 (150 x 4.6 mm, 5 μm) column and the mobile phase consisted of acetonitrile: 0.025 M phosphate buffer adjusted to pH 3 (70:30 v/v) pumped at a flow rate 0.8 mL/min and UV-detection was performed at 210 nm. The proposed method was validated according to ICH guidelines (linearity, limit of detection, limit of quantification, precision, accuracy, recovery and system suitability). The total run time was less than 3 min and the retention time for Enalapril maleate was 2.3 min. The calibration graph was linear in the concentration range between 10 – 100 μg/mL with the correlation coefficient r2 = 0.9998. The developed and validated method was successfully applied to determine the Enalapril maleate in tablets. Therefore, this method proved to be sensitive, specific and reproducible and can be applied for routine analysis of enalapril maleate from pharmaceutical formulation due to its simplicity of application.
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来源期刊
Ovidius University Annals of Chemistry
Ovidius University Annals of Chemistry CHEMISTRY, MULTIDISCIPLINARY-
自引率
11.10%
发文量
20
审稿时长
5 weeks
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