Comparative Quality Control Study of Different Brands of Diclofenac Sodium Tablet Available in Local and Government Pharmacies by In-Vitro Testing.

Abstract

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.