Chemical equivalence studies of three brands of aspirin tablets
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Date
2011
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Publisher
Faculty of Pharmaceutical Sciences, Ahmadu Bello University Zaria
Abstract
Three brands of Aspirin were analyzed for chemical equivalence studies. The biopharmaceutical parameters considered are Uniformity of Weight, identification, assay, disintegration, friability, hardness, and dissolution tests using B.P 2002 specification. Brands 02 and 03 complied to the B.P specification for the Weight Uniformity test. Brand 01 did not meet the B.P standard for the Weight Uniformity test. The values for the % content using the back titration procedure as specified by the B.P 2002 showed that Brands 01 and 02 had 118.004% and 127.01% respectively hence both Brands did not comply with the specified B.P standard of 95%-105%. Only Brand 03 passed the Assay test with a 98.18% percentage content of Aspirin. Brands 01, 02 and 03 passed the disintegration test showing 9.11 minutes and 13.1 and 6.67 minutes respectively which comply with standard ≤15 minutes for uncoated tablets. Brand 02 failed the friability test with a result of 9.32% weight loss as compared to the 1% maximum weight loss specified in the B.P Monograph. Brands 01 and 03 met with this specification with 0.307% and 0.29% weight loss respectively. Brands 01, 02, and 03 gave 8KgF, 4KgF, and 4.5KgF respectively in response to the Crushing Strength Test. All the Brands passed the Hardness test which has a specification of 4-15KgF as standard. The values obtained for dissolution after 45 minutes for Brand 01=71.67%, Brand 02=62.5% and Brand 03=77.5%. The overall result showed that all the three brands are not chemically equivalent to each other since Brand 02 did not meet the official standard of 70% release.
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Keywords
Chemical Equivalence, Aspirin, Assay, Dissolution, Friability