Gupta Madan Mohan, Khoorban Avinash, Ali Ahamad, Ramlogan Ornella, Talukdar Debjyoti
School of Pharmacy, Faculty of Medical Sciences, The University of the West Indies, St. Augustine, TTO.
College of Pharmacy, Teerthanker Mahaveer College of Pharmacy, Moradabad, IND.
Cureus. 2020 Nov 5;12(11):e11348. doi: 10.7759/cureus.11348.
The objective of this study is to conduct in-vitro quality control testing of diclofenac sodium tablets involves weight variation test, drug assay, friability test, and the disintegration and dissolution test. Two brands of diclofenac sodium tablets were used in the study, named Brand A and Brand B. Quality control (QC) test results for diclofenac sodium tablets show that both Brand A and Brand B conform to the United States Pharmacopeia (USP) standards. In terms of weight variation, Brand A and B have an above the mean weight limit variation of 2.79% and 2.05%, respectively. The lower mean weight limit variations are 1.21% and 1.27%, respectively, which are within the 10% standard limits of USP. Friability tests show that Brands A and B have an average friability of 0.062% and 0.01% mass loss, which are within the 1% mass loss limits of USP. In terms of drug assay, both Brands A and B fall under the USP parameter of 85%-115%, respectively. The disintegration test shows that Brand A and Brand B fall within a 15-minute time interval segment with disintegration time calculated as 6.69 min and 7.02 min for Brands A and B, respectively. Brand B of Diclofenac Sodium has a drug dissolution percentage of 90.7% within a 45-min sampling time interval. Brands A and B pass the pharmacopeia limits set under the USP standards. The friability test shows that the loss of mass for both Brands A and B was within the 1% standard limit. Similarly, with regard to weight variation, both brands conform under the normal limit of 10% above or lower the mean weight. In terms of drug assay, both brands' drug availability was within the specified 85%-115% standard range. They passed the disintegration and dissolution test within a time limit of less than 15 minutes and 45 minutes, respectively.
本研究的目的是对双氯芬酸钠片剂进行体外质量控制测试，包括重量差异测试、药物含量测定、脆碎度测试以及崩解和溶出度测试。研究中使用了两个品牌的双氯芬酸钠片剂，分别为品牌A和品牌B。双氯芬酸钠片剂的质量控制（QC）测试结果表明，品牌A和品牌B均符合美国药典（USP）标准。在重量差异方面，品牌A和品牌B高于平均重量限制的差异分别为2.79%和2.05%。较低的平均重量限制差异分别为1.21%和1.27%，均在USP的10%标准限度内。脆碎度测试表明，品牌A和品牌B的平均脆碎度质量损失分别为0.062%和0.01%，均在USP的1%质量损失限度内。在药物含量测定方面，品牌A和品牌B分别符合USP参数的85%-115%。崩解测试表明，品牌A和品牌B在15分钟的时间间隔内崩解，品牌A和品牌B的崩解时间分别计算为6.69分钟和7.02分钟。双氯芬酸钠品牌B在45分钟的采样时间间隔内药物溶出百分比为90.7%。品牌A和品牌B通过了USP标准设定的药典限度。脆碎度测试表明，品牌A和品牌B的质量损失均在1%标准限度内。同样，在重量差异方面，两个品牌均符合平均重量上下10%的正常限度。在药物含量测定方面，两个品牌的药物可用性均在规定的85%-115%标准范围内。它们分别在不到15分钟和45分钟的时间限制内通过了崩解和溶出度测试。
