Lisinopril Tablet Quality Evaluation: A Pharmacopeial Compliance Study
DOI:
https://doi.org/10.63623/hcfv6209Keywords:
Lisinopril, Pharmacopeial compliance, Quality assurance, High performance liquid chromatographyAbstract
Background: The quality of pharmaceutical products is critical in ensuring therapeutic efficacy and patient safety, particularly in managing chronic conditions like hypertension. Objectives: This study assessed the quality of five different brands of Lisinopril tablets using pharmacopeial standards to evaluate their compliance with required specifications. Methods: Five brands were analyzed through High-Performance Liquid Chromatography (HPLC), weight uniformity, hardness, friability, and disintegration tests. HPLC was employed for content assay, while mechanical and release characteristics were assessed using pharmacopoeial protocols. Results: HPLC analysis showed that all brands contained Lisinopril within the USP acceptable range of 90–110% of the labeled claim. The weight uniformity test confirmed compliance, with all brands falling within the ±7.5% limit. Hardness values varied significantly: brands PR, FI, and ED passed with mean values of 8.5 KgF, 8.3 KgF, and 5.0 KgF respectively, while brands LF and RL failed with values of 3.7 KgF and 3.3 KgF. Friability percentages ranged from 0.105% (FI) to 0.842% (LF), well below the 1% limit. Disintegration times also varied, with all brands meeting the pharmacopeial standard of <15 minutes for uncoated tablets; however, Prilas disintegrated fastest, and Fidson the slowest, indicating variability in onset of action. Conclusion: All brands tested complied with pharmacopeial specifications for active content, friability, and disintegration. However, variations in hardness and disintegration times may influence tablet performance and clinical outcomes. These findings underscore the importance of comprehensive quality evaluation in ensuring consistent therapeutic efficacy.
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Copyright (c) 2025 Faizah Modupe Bakre, Adekunle Olatunde Ayodele, Iyanu Oluwafemi Awotuya, Katherine Olabanjo Olufolabo, Fagbohun Ayodele Babasola, Olabanji John Daodu, James Olatunde Olaitan, Saka Lateef Kasim
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