药物制剂中3-氨基甲基己酸的动力学测定方法

IF 0.8 4区 化学 Q4 CHEMISTRY, MULTIDISCIPLINARY
F. Siddiqui, Nawab Sher, Asia Naz, Najmul Hasan, S. N. Shah, Muhamad Shehzad
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引用次数: 1

摘要

建立了一种简单、灵敏的化学动力学比色分光光度法定量测定原料药和制剂中3-氨基甲基己酸(普瑞巴林)的方法。显色剂茚三酮与普瑞巴林在70℃下反应,在575 nm处测定吸光度,并评价吸光度与时间的动力学相关性。采用初始速率法、速率常数法和固定时间(80 min)法对普瑞巴林在10 ~ 30 μ mL范围内的含量进行了测定,三者的LOD值在1.2 ~ 1.5 μ mL之间,LOD值在0.76 ~ 0.95 μ mL之间,相关性均为bb0 0.9990。采用ICH建议进行了方法验证,并对各变量进行了评价和优化。该方法具有良好的回收率(98.38 ~ 102.12%)和精密度(RSD < 1.4%),可用于制剂中普瑞巴林的测定。根据Benesi-Hildebrand方程,标准自由能变化和缔合常数分别为1.212 × 10和-4.747。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Kinetic Approach to Determine 3-Amino Methyl Hexanoic Acid in Pharmaceutical Formulations
A simple and sensitive colorimetric spectrophotometric method based on application of chemical kinetics was produced and developed for the quantitative determination of 3-amino methyl hexanoic acid (pregabalin) in bulk and pharmaceutical preparations. Ninhydrin, a chromogenic agent was reacted with pregabalin at 70 °C and the absorbance was measured at 575 nm and kinetic correlation was evaluated between absorbance and time. The initial-rate, rate-constant and fixed-time (80 min) methods were employed for the estimation of pregabalin in the range of 10–30 μg mL which showed good correlation >0.9990 in all three cases with LOQ values ranging from 1.2–1.5 μg mLand LOD values ranging from 0.76–0.95 μg mL. Method validation was carried out using ICH recommendations and the variables were evaluated and optimized. The newly developed method has useful applications to determine pregabalin in pharmaceutical formulation with good recovery (98.38 to 102.12 %t) and precision (RSD < 1.4 %). Standard free energy changes and association constant were found to be 1.212 × 10 and –4.747, respectively, as determined by the Benesi–Hildebrand equation.
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来源期刊
CiteScore
3.10
自引率
0.00%
发文量
6
审稿时长
>12 weeks
期刊介绍: Original work in all branches of chemistry is published in the South African Journal of Chemistry. Contributions in English may take the form of papers, short communications, or critical reviews.
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