INVITRO ASSESSMENT AND APPLICATION OF KINETICS MODELS ON DISSOLUTION PROFILE OF SEVERAL BRANDS OF CLOPIDOGREL (75MG) AVAILABLE IN KARACHI, PAKISTAN
invitro and kinetic evaluation of several brands of clopidogrel 75 mg
Abstract
Objective: The main objective of this study is to perform the invitro quality assessment of ten different marketed brands of Clopidogrel (75mg) available in the Karachi, Pakistan.
Methodology: Pharmacopoeial and non pharmacopoeial test have been performed on all ten selected brands of Clopidogrel coded as C1, C2, C3…C10. A sample of 10 tablets from each brand were subjects to performed pharmacopoeial test such as weight variation, friability, disintegration, assay and dissolution. Non pharmacopoeial test include hardness, thickness and diameter. All the dissolution data were subjected to model dependent and model independent kinetics approaches.
Result: The average weight variation of all ten coded brands of Clopidogrel were found to be 225.9-356.1 mg, followed the USP specification of ±7.5% deviation. After performing hardness, thickness and diameter of all selected tablets, the values were found to be in specified limited given by USP. The disintegration time of all test formulation was 2-8minutes, which meet the USP standard disintegration limit of film coated tablets. % friability of tested tablets was found to be 0.02-0.3%, which lies in the standard limit of % friability of bearing enough mechanical strength. In this study assay studies of Clopidogrel was found to be in the range of 98.7% to 101.30%, which lying under the limits of USP assay monograph. The dissolution test was subjected to model dependent and model independent kinetics approaches by using Dissolution Data solver (DD solver). 0.1N HCl were used for multiple point dissolution studies, range of 90.9%-99.8% drug released was analyzed on UV spectrophotometer at the wavelength of 270nm which also found to be in USP specifications. The fundamental measures of similarity factor (f1) and dissimilarity factor (f2) values were also found to be in limits. After applying all the kinetics models on coded brands of Clopidogrel, the calculated r2 value followed all model kinetics approaches.
Conclusion: In this successful study, application of pharmacopoeial and non pharmacopoeial test on ten different coded brands of Clopidogrel (75mg) available in Karachi, Pakistan. Further work is recommended on large scale sample. All the values were found to be in limits and meets the specifications given by the United State Pharmacopeia. Moreover, invitro multiple point dissolution studies were carried out by the application of Dissolution Data solver (DD solver) and were subjected to all kinetics models.
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