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开发一种用于测定各种药物中头孢地尼的分光光度分析方法。

Development of a spectrophotometric analytical approach for the measurement of cefdinir in various pharmaceuticals.

作者信息

Mahmood Ali Khalil, Sallal Takleef Dheyab, Al-Janabi Khalid Waleed S, Luaibi Hasan Mohammed

机构信息

Department of Chemistry, College of Education for Pure Sciences/Ibn Al-Haitham, University of Baghdad, Baghdad, Iraq.

Ministry of Education, Baghdad, Iraq.

出版信息

J Adv Pharm Technol Res. 2023 Jul-Sep;14(3):263-268. doi: 10.4103/japtr.japtr_285_23. Epub 2023 Jul 28.

Abstract

An accurate and sensitive determination procedure has been established for the quantification of cefdinir in pure and pharmacological formulas. The approach was dependent on derivatizing cefdinir with sodium anthraquinone-2-sulfonate (SAS) in an alkaline medium to produce a magenta-colored derivative with a maximum absorbance at 517 nm against the reagent blank. Different factors affecting the interaction of cefdinir with SAS were studied carefully and optimized, such as the buffer value, medium acidity, the duration of hydrolysis, and the reagent percentage. Under optimized conditions, a linear calibration curve with a correlation coefficient of = 0.9995 was obtained over the concentration range of cefdinir 0.5-100 μg/mL. The values of the parameters that represented the sensitivity of the method were satisfactory, i.e., the limit of detection, the limit of quantification, as well as Sandell's sensitivity () were 0.1 μg/mL, 0.5 μg/mL, and 0.064 μg/cm/0.001 Au, respectively. The relative standard deviation was below 1.35%, while the percentage recovery was 99.930%-102.257%. The mole ratio of the colored complex was estimated by following Job's method of continuous variation, which indicated that the cefdinir-SAS ratio was 1:1. The suggested approach was proven to be adequately accurate, precise, and without interfering with common excipients and additives. Thus, it could be implemented successfully for the standard determination of cefdinir in its pure and pharmaceutical forms.

摘要

已建立一种准确且灵敏的测定方法,用于定量纯品和药物制剂中的头孢地尼。该方法基于在碱性介质中用蒽醌 - 2 - 磺酸钠(SAS)将头孢地尼衍生化,生成一种洋红色衍生物,相对于试剂空白在517 nm处有最大吸收。仔细研究并优化了影响头孢地尼与SAS相互作用的不同因素,如缓冲液值、介质酸度、水解时间和试剂比例。在优化条件下,头孢地尼浓度范围为0.5 - 100 μg/mL时,获得了相关系数为 = 0.9995的线性校准曲线。代表该方法灵敏度的参数值令人满意,即检测限、定量限以及桑德尔灵敏度()分别为0.1 μg/mL、0.5 μg/mL和0.064 μg/cm/0.001 Au。相对标准偏差低于1.35%,回收率为99.930% - 102.257%。通过采用乔布连续变化法估算有色络合物的摩尔比,结果表明头孢地尼与SAS的比例为1:1。所建议的方法经证明具有足够的准确性、精密度,且不干扰常见辅料和添加剂。因此,它可成功用于头孢地尼纯品及其药物制剂的标准测定。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d38f/10483900/4ab4eac83bc9/JAPTR-14-263-g001.jpg

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