Application of Quality Control Parameters and Model Dependent and Independent Approaches on Different Brands of Itopride HCL 250mg Available in Karachi, Pakistan

Abstract

Objective: To conduct Invitro Quality testing of five different brands Itopride Hcl (250mg) available in
Karachi, Pakistan to ensure that their quality meet the desired compendial standards.
Methodology: Several In-vitro tests were executed on five different brands of Itopride Hcl coded as 11, 12,
13, I4 and I5. Sample of 20 tablets from individual selected brands were subjected to different tests including
weight variation, hardness, thickness and diameter. Multiple point intervals dissolution were performed in
0.1N HcL medium in USP paddle type II apparatus and % dissolution data were subjected to several kinetic
model including model dependent and model independent approaches utilizing DD solver add in program
in Microsoft Excel.
Result: Weight variation of all five coded brands of Itopride Hcl 250 mg were found to be 133- 311mg. The
disintegration time of all test formulation was between 2 minutes 40 seconds and 9minutes 32 seconds, %
friability of all tested tablets was found to be 0.21-0.57%. Multiple point dissolution studies samples were
taken at 5, 10, 15, 20, 25 and 30 minutes and drug released was analyzed on UV spectrophotometer at the
wavelength of 258nm.Similarity factor (f1)considering I2 as reference formulation were found to be in the
range of 1.86-6.52 and dissimilarity factor (f2) values were found to be in the range of 61.80-84.87. Kinetic
models were successfully applied to the dissolution profile of Itopride Hcl.
Conclusion: Evaluation of the quality attributes of five different selected brands of itopride 250 mg tablets
in Karachi, Pakistan, specifically assessing weight variation, hardness, thickness, diameter, dissolution, and
disintegration was the primary objective of this study. By adhering to established Pharmacopeial standards
ensure the product's quality, efficacy, and safety. Tablets ability to release active pharmaceutical ingredient
in a timely manner improving patient compliance by providing optimum therapeutic activity. Invitro quality
standards ensure the products accuracy in terms of weight, potency and performance. The study high light
the importance of rigorous quality control in pharmaceutical manufacturing contributing to improved patient
outcomes.