Physicochemical analysis and quality assessment of Lisinopril oral formulations used in the management of hypertension

Abstract

Background: Hypertension (HT) is one of the primary causes of death worldwide, accounting for 13% of all deaths. Most cardiovascular disease (CVD) outbreaks in Africa are driven by hypertension, although global detection, awareness, treatment, and control rates are low. Aim: the study aimed to analyze the physicochemical parameters and quality assessment of different brands of Lisinopril. Method: Five (5) brands of Lisinopril oral tablets (10mg) were purchased and coded LSP1, LSP2, LSP3, LSP4, and LSP5. Different test including weight uniformity, standardizations, extraction, titrimetric (aqueous and non-aqueous) analysis, and quality determination of all the brands was conducted using standard procedures outlined in the United States Pharmacopoeia (USP). Result: All brands of Lisinopril used in the analysis conformed to the weight uniformity test. LSP1 conformed to the standard purity range in aqueous titrimetric analysis (98.5%), while the other brands had a close percentage but did not fall within the stated standard with a percentage purity of 82.2% (LSP2), 75.5% (LSP3), 87.1% (LSP4), and 75.6% (LSP5), respectively. For the non-aqueous titration, LSP 1 and LSP 2, conform to the standard percentage purity outlined in the USP, with 100.65% (LSP1), and 97.55% (LSP2). The brands had a percentage purity of 72.78% (LSP3), 88.26% (LSP4), and 88.26% (LSP 5), respectively. Conclusion: the method used in this study can be easily employed in the quality assessment and physicochemical analysis of solid dosage formulations commonly utilized by patients because it is rapid, efficient, cost-effective, less technical and reproducible.