A comparative analysis of in-process quality control test of generic vs. brand Enalapril maleate tablets

Mhaske, Shubham and Satpute, Uday and Satwadhar, Manik and Sayyad, Shifa (2025) A comparative analysis of in-process quality control test of generic vs. brand Enalapril maleate tablets. International Journal of Science and Research Archive, 15 (2). pp. 427-438. ISSN 2582-8185

This study compares a generic drug (Eopril-5) and a brand drug (Envas-5) to evaluate the quality control parameters of Enalapril Maleate 5 mg tablets. Enalapril maleate is an angiotensin-converting enzyme (ACE) inhibitor that is frequently administered to treat heart failure and hypertension. Comprehensive physicochemical quality control testing is essential to verifying treatment efficacy and patient safety. The formulations are evaluated in this study using both official and unofficial quality control procedures, including FTIR spectroscopy, weight variation, hardness, friability, disintegration, and dissolution. Unofficial tests were also conducted to evaluate properties like thickness, hardness in order to gather further information on the formulation's quality. General appearance evaluation showed that both formulations had acceptable visual uniformity in color, shape, and surface texture. The generic formulation showed a little increase in weight variance and friability, suggesting possible areas for production process improvement. Dissolution testing confirmed that both formulations released at least 80% of the drug within 30 minutes, satisfying USP criteria, and dissolution profile comparison demonstrated comparable drug release behavior. Disintegration times for both products were well within the 15-minute limit, ensuring rapid breakdown for absorption. FTIR spectra confirmed the chemical integrity of the formulations and showed that the active component is present in both products in the correct molecular form. The study highlights the importance of comprehensive quality control testing to ensure clinical comparability between brand-name and generic pharmaceutical medications.