ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF CEFIXIME TRIHYDRATE IN BULK AND DOSAGE FORM BY UV-VISIBLE SPECTROSCOPY

A. A. Chowdhury, Masuma Akter Brishti, Giyas Uddin, Fazlul Karim Tipu, Shaila Kabir, Md. Shah Amran
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引用次数: 1

Abstract

Objective: This work aimed to validate a simple UV-Visible spectrophotometric method for estimating Cefixime trihydrate in bulk and to produce an accurate, precise, repeatable, and cost-effective method. Material and Methods: The pH 7.4 Phosphate buffer was utilized as the solvent throughout the experiment. The drug’s absorption maxima (max) were discovered to be at 288 nm. Beer’s law was found to be obeyed in the range of 10-45 μg/mL during the quantitative analysis of the substance at 288 nm. In the doses tested, the approach was found to be linear, with the line equation y = 0.035x – 0.002 and a correlation coefficient of 0.999. Results and Discussion: Cefixime Trihydrate recovery values varied from 99.656 percent to 101.825 percent. Six duplicates of the experiment had a relative standard deviation of less than 2%. The interday precision range was 0.52-1.02%, and the intraday precision range was 0.57-0.995 percent relative standard deviation (RSD percent). The detection and quantification limits were 0.914 and 3.142 μg/mL, respectively. The method’s robustness and ruggedness had a percent relative standard deviation of 0.532-0.827 percent. Conclusion: As a result, the proposed procedure was precise, accurate, and economical. This method could be used to determine the quantity of medicine in bulk.
紫外可见光谱法测定三水合头孢克肟原料药和剂型的分析方法
目的:建立一种简便的紫外-可见分光光度法定量测定三水合头孢克肟的方法,并建立一种准确、精密度高、重复性好、成本效益好的方法。材料与方法:整个实验均以pH 7.4的磷酸盐缓冲液为溶剂。药物的最大吸收峰(max)在288 nm处。在288 nm定量分析时,发现该物质在10 ~ 45 μg/mL范围内符合Beer定律。在试验剂量中,发现该方法是线性的,线性方程为y = 0.035x - 0.002,相关系数为0.999。结果与讨论:三水合头孢克肟回收率为99.656% ~ 101.825%。6次重复实验的相对标准偏差小于2%。日内精密度范围为0.52 ~ 1.02%,日内精密度范围为0.57 ~ 0.995% (RSD %)。检测限和定量限分别为0.914和3.142 μg/mL。该方法的稳健性和耐用性的相对标准偏差为0.532 ~ 0.827%。结论:该方法精确、准确、经济。该方法可用于散装药品的定量测定。
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