In Vitro Assay and Dissolution Study of Diclofenac Sodium Tablets Marketed In Port Harcourt, South – South Nigeria

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Abstract

The aim of this study is to determine the potency of Diclofenac sodium tablet available in Port Harcourt metropolis, south-south Nigeria. Diclofenac Sodium is a potent Non-Steroidal Anti-Inflammatory Drug (NSAID) commonly used as an Over the Counter (OTC) drug. Potency determination was performed to evaluate and authenticate whether the marketed samples complies with the declared specification. In vitro dissolution study was, performed to verify the potency of the drug and its relative bioavailability. Hardness was checked to verify whether it interferes with the dissolution, which might ultimately affect the drug bioavailability. In this present study, a simple, cost effective, and spectrophotometric method for the potency determination of marketed diclofenac sodium tablets is used. Six samples were randomly collected from the market and coded as A, B, C, D, E and F, and the potency determined are 80%, 98.7%, 126.9%, 99.6%, 109.2% and 91.4% respectively. Hardness and in vitro dissolution of the six brands of diclofenac sodium tablet were studied and reported. After 1 h dissolution release of samples A, B, C, D, E, and F are 135%, 30%, 70%, 122%, 38%, and 40% respectively. The results obtained from the study signified, that not all the samples analyzed complied with the BP and USP standards or requirements.
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尼日利亚南南部哈科特港市售双氯芬酸钠片体外测定及溶出度研究
本研究的目的是确定尼日利亚南南哈科特港市双氯芬酸钠片的效价。双氯芬酸钠是一种有效的非甾体抗炎药(NSAID),通常作为非处方(OTC)药物使用。效价测定是为了评估和验证上市样品是否符合声明的规格。体外溶出度研究验证了该药物的效价和相对生物利用度。检查硬度以验证其是否干扰溶出,这可能最终影响药物的生物利用度。本研究采用一种简单、经济、高效的分光光度法测定市售双氯芬酸钠片的效价。随机抽取市场样品6份,编码为A、B、C、D、E、F,测定效价分别为80%、98.7%、126.9%、99.6%、109.2%、91.4%。对6种牌子双氯芬酸钠片的硬度和体外溶出度进行了研究。样品A、B、C、D、E、F溶出1 h后的释放度分别为135%、30%、70%、122%、38%、40%。研究结果表明,并非所有分析的样品都符合BP和USP的标准或要求。
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