A Developed Method for the Estimation of Diclofenac Sodium via Coupling with Diazotized 4-Aminoacetophenone

S. Fadhel, A. S. Al-kadumi, Nuha A. Imran, Marwah H. Abdulateef
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Abstract

A recommended, simple and sensitive method for the spectrophotometric determination of diclofenac sodium drug (DLC) in pharmaceutical formulations was represented in this work. The method is based on the coupling of DLC with diazotized 4-Aminoacetophenone in basic medium to form an intense yellowish-brown colored diazocoupling product that showed maximum absorbance at 362 nm. The effect of various factors such as amount of the reagent, time of the reaction and order of addition were investigated. The experimental results indicated a good linearity (r = 0.9954) over a concentration range of (240) μg.mL with a detection limit of 0.447 μg.mL diclofenac sodium under the optimized conditions. The pharmaceutical excipients did not exhibit any interferences. The low value of the standard deviation alongside good correlation coefficient confirms the applicability of the method. Accordingly, the proposed method has been successfully applied to the determination of diclofenac sodium in pharmaceutical formulations. The results were statistically compared with standard methods by means of t-test and f-test at 95% confidence level with no significant differences observed.
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双氯芬酸钠与重氮化4-氨基苯乙酮偶联测定方法的建立
建立了一种简便、灵敏的分光光度法测定制剂中双氯芬酸钠的方法。该方法是将DLC与重氮化的4-氨基苯乙酮在碱性介质中偶联,形成强烈的黄褐色重氮偶联产物,在362 nm处吸光度最大。考察了试剂用量、反应时间、加料顺序等因素对反应的影响。实验结果表明,在(240)μg的浓度范围内线性良好(r = 0.9954)。检出限为0.447 μg。在最佳条件下制备mL双氯芬酸钠。药物赋形剂没有表现出任何干扰。低的标准差值和良好的相关系数证实了该方法的适用性。因此,所提出的方法已成功地应用于药物制剂中双氯芬酸钠的测定。结果与标准方法比较,采用95%置信水平的t检验和f检验,差异无统计学意义。
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