ISSN : 2663-2187

In-Vitro Evaluation of Different Marketed Brands of Metformin Tablets Using Quality Control Tests

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Mrs. Anjali Peter, Ms.Kirti Tomar, Mr.Rakesh Solanki, Ms. Pratibha Bhide, Mrs.Harsha Parihar, Ms ApurvaJoshi, Mr.Anuj Agrawal, Ms Deepika Roy
» doi: 10.48047/AFJBS.6.Si4.2024.1827-1846

Abstract

Type II diabetes is a prevalent metabolic disorder, particularly affecting obese individuals, where effective management is crucial for mitigating associated health risks. Metformin, a frontline anti-diabetic medication, is widely prescribed due to its efficacy and cost-effectiveness. However, the availability of numerous brands of metformin tablets poses a challenge for healthcare providers and patients in selecting the most suitable option. This study aimed to evaluate the performance of four selected brands of 500 mg metformin tablets, focusing on their physical and chemical parameters using established methods. The evaluation encompassed several key parameters, including uniformity of weight, friability, hardness, disintegration time, dissolution profile, and drug content, adhering strictly to standards outlined in the United States Pharmacopeia (USP) and Indian Pharmacopoeia (IP). All brands underwent rigorous testing to ensure consistency and adherence to pharmacopoeial specifications. The results of the evaluation revealed that all four brands of metformin tablets met the specified limits for weight variation and friability, indicating uniformity and stability in their formulations. Furthermore, the disintegration time for each brand fell within the recommended threshold of 15 minutes, as per official guidelines, suggesting efficient breakdown and absorption within the gastrointestinal tract. Moreover, all brands demonstrated satisfactory performance in the in-vitro dissolution rate test, with over 80% drug release observed within 30 minutes, ensuring adequate bioavailability and pharmacokinetic profiles. UV analysis confirmed that the active ingredient content in all brands remained within the monograph specification range of 95 – 105 %, affirming consistency in drug concentration and potency. Although variations were observed in the performance metrics among the different brands evaluated, collectively, they met the pharmacopoeial specifications for quality control. Therefore, based on the findings of this study, any of the evaluated brands can be freely substituted if one brand becomes unavailable or inaccessible. In conclusion, this study provides valuable insights into the performance of various brands of 500 mg metformin tablets, facilitating informed decision-making for healthcare providers and patients in the management of type II diabetes, especially in obese individuals. The adherence of all brands to established pharmacopoeial standards underscores their safety, efficacy, and inter-changeability, ensuring consistent therapeutic outcomes.

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