HPLC-MS测定盐酸美金刚溶出度方法的建立与验证

IF 0.7 Q4 CHEMISTRY, ANALYTICAL
A. Yegorova, Yu. V. Skrypynets, I. Leonenko, G. Maltsev, S. Kashutskуy, O. Voitiuk
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引用次数: 0

摘要

建立了适用于盐酸美金刚IС片溶出度分析的高效液相色谱-质谱法(HPLC- ms)定量测定盐酸美金刚的方法。色谱测定采用流动相甲醇- 0.1% (v/v)甲酸水溶液(55:45),色谱柱为Zorbax Eclipse Plus C18,尺寸为10 cm Ч 4.6 mm (3.5 μm),流速为1 ml/min。适宜溶出介质的线性区间为片中盐酸美金刚标准含量的35 ~ 150%。该方法的特异性、准确性、正确性、在所研究浓度范围内的线性、稳健性等参数均得到了验证。在室温下储存24小时的情况下,测试溶液和参考溶液的稳定性得到了证实。研究发现,在0.1 M盐酸溶液pH为1.2的溶解介质中制备的溶液中,分析前需要对盐酸进行预中和,因为盐酸比甲酸更强,几乎完全电离了所有溶解的分子,导致分析信号对分析物浓度的线性依赖性明显偏离。中和用0.1 M氢氧化钠溶液,加入到测试溶液的样品中。在所有溶出介质中,15分钟内释放量大于85%的盐酸美金刚表明溶出曲线相似,不需要计算相似因子f2。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Development and Validation of HPLC-MS Method of Determination of Memantine Hydrochloride for Study of Dissolution Profiles
A method for quantitative determination of memantine hydrochloride by HPLC with mass spectrometric detection (HPLC-MS), suitable for the study of dissolution profiles of tablets "Mematon IС" was developed. Chromatographic determination was performed using a mobile phase of methanol - 0.1% (v/v) aqueous solution of formic acid (55:45) on a column of Zorbax Eclipse Plus C18 size 10 cm Ч 4.6 mm (3.5 μm) at a flow rate of 1 ml/min. The linearity interval in the appropriate dissolution media is 35 - 150 % of the normalized content of memantine hydrochloride in the tablet. The method is validated on the parameters of specificity, accuracy, correctness, linearity in the studied range of concentrations, robustness. The stability of the tested solutions and reference solutions in the case of their storage at room temperature for 24 hours was confirmed. It is established that in the case of the study of solutions prepared in a dissolution medium of 0.1 M hydrochloric acid solution pH 1.2, there is a need to preneutralize hydrochloric acid before analysis, because it, as stronger than formic acid, almost completely ionizes all dissolved molecules, which leads to a significant deviation of the linear dependence of the analytical signal on the concentration of the analyte. Neutralization is performed with 0.1 M sodium hydroxide solution, which is added to the sample of the test solution. The release of more than 85 % of memantine hydrochloride in 15 min in all dissolution media indicates the similarity of the dissolution profiles and does not require the calculation of the similarity factor f2.
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来源期刊
CiteScore
1.00
自引率
14.30%
发文量
12
期刊介绍: The journal "Methods and objects of chemical analysis" is peer-review journal and publishes original articles of theoretical and experimental analysis on topical issues and bio-analytical chemistry, chemical and pharmaceutical analysis, as well as chemical metrology. Submitted works shall cover the results of completed studies and shall make scientific contributions to the relevant area of expertise. The journal publishes review articles, research articles and articles related to latest developments of analytical instrumentations.
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