比色电荷转移络合物在原料药和制剂中测定头孢多肟的开发和验证

IF 0.8 4区 化学 Q4 SPECTROSCOPY
Elif Ozdemir, Ayca Karasakal
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引用次数: 0

摘要

头孢多肟(CFP)是第三代头孢菌素类抗生素,是一种抗菌β -内酰胺类药物,用于治疗急性中耳炎、咽炎、扁桃体炎和下呼吸道感染(如肺炎和支气管炎)。建立了一种简便、快速、灵敏的分光光度法测定原料药和制剂中头孢多肟的含量。该方法是基于头孢吡肟为n电子给体,7,7,8,8-四氧基喹啉二甲烷(TCNQ)为π受体的电荷转移相互作用。此外,根据ICH指南的要求对所述方法进行了验证。在596 nm处测定吸光度。并对线性度、定量限、定量限、准确度、精密度、回收率等参数进行了评价。在3.0 ~ 15.0 μg/mL浓度范围内呈线性关系。CFP的相关系数为0.9997。定量限和定量限分别为0.036和0.108 μg/mL。采用标准加样法,加样回收率为99.97 ~ 101.3%。通过学生t检验和方差比f检验对所提方法的性能进行评价,找出所提方法相对于参比分光光度法的显著性。该方法已成功地应用于中药制剂和纯品中CFP的测定。
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 the Colorimetric Charge Transfer Complex for Estimation of Cefpodoxime Proxetil in Bulk and Pharmaceutical Preparations

Cefpodoxime proxetil (CFP) is a third-generation cephalosporins group antibiotic which is an antibacterial beta-lactam agent that is used in the treatment of acute otitis, pharyngitis, tonsillitis and lower respiratory tract infections (e.g. pinomonia and bronchitis). A simple, fast and sensitive spectrophotometric method was developed for the determination of cefpodoxime proxetile in bulk and pharmaceutical preparations. The proposed method was based on the charge transfer interactions of cefpodoxime proxetil as n-electron donor with 7,7,8,8-tetracyan oquinodimethane (TCNQ) as the π-acceptor. In addition, the described method was validated in accordance with the requirements of ICH guidelines. The absorbance was measured at 596 nm. The parameter of linearity, LOD, LOQ, accuracy, precision and recovery were also evaluated. The assay was linear over the concentration range of 3.0–15.0 μg/mL. The correlation coefficient was obtained 0.9997 for CFP. LOD and LOQ values were found to be 0.036 and 0.108 μg/mL, respectively. Recovery values were obtained ranging from 99.97 to 101.3% according to the standard addition method. The performance of the proposed method was evaluated in terms of the student’s t-test and variance ratio F-test to find out the significance of the proposed methods over the reference spectrophotometric method. The developed method was successfully applied for estimation of CFP in a pure form and as a pharmaceutical preparate.

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来源期刊
CiteScore
1.30
自引率
14.30%
发文量
145
审稿时长
2.5 months
期刊介绍: Journal of Applied Spectroscopy reports on many key applications of spectroscopy in chemistry, physics, metallurgy, and biology. An increasing number of papers focus on the theory of lasers, as well as the tremendous potential for the practical applications of lasers in numerous fields and industries.
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