Prediction of Kinetic Models on Dissolution Profileand in Vitro Quality Control Analysis on Several Brands of Ebastine (10mg) Available in Karachi, Pakistan

Purpose: This investigation focuses on conducting a comprehensive in vitro standard evaluation of 10 different Brands Ebastine tablets (10mg) available in Karachi, Pakistan. The basic findings of this study is to ensure that the selected Ebastine brands from Karachi, Pakistan meet the in vitro quality parameters as specified in United states Pharmacopeia. Methodology: The study involved application of Pharmacopeial and non Pharmacopeial tests on 10 different brands on Ebastine tablets Including weight variation, friability, disintegration, dissolution, assay and thickness, diameter, hardness. Model dependent and independent approaches were applied included First-order, Higuichi, Hixson Crowell and Well model and model dependent approaches the difference (f1) and similarity (f2) factors for were applied on multiple point dissolution data through Dissolution Data solver (DD- Solver) an add-in program in Excel. Result: The average weight variation of ten brands of Ebastine brands fell within the USP specification of ±7.5% deviation (193-212 mg). Hardness of Ebastine were found to be in the range of 4.38±0.1-4.98±0.5 kg which meets the standard value 4-10 kg. Thickness of Ebastine is 1.25±0.2-1.43±0.2mm and diameter was fond to be 3.02±0.2-5.59±0.4 mm. Disintegration time of all ten selected brands of Ebastine was below 15 minutes. Friability ranged from 0.8- 0.91% within the standard limit, indicating tablets’ sufficient mechanical strength. Several kinetic models were successfully applied using DD Solver an add in Program in Excel it was concluded on the basis of r2 0.9903 value all ten brands of Ebastine followed weibull model and f1 similarity and f2 dissimilarity values were found to be 3.59-10.96 & 50.44-71.56. Conclusion: The study successfully conducted Pharmacopeial and non-Pharmacopeial tests on ten different brands Ebastine 10 mg brands accessible in Karachi, Pakistan, indicating conformity with USP specifications.