Development and validation of a UV-spectrophotometric method for determination of an ACE inhibitor in pharmaceutical formulations.

Introduction

Fosinopril sodium, an angiotensin-converting enzyme inhibitor, is a widely prescribed antihypertensive agent and one of the leading drugs approved for use in hypertension management. Despite its clinical relevance, no UV-spectrophotometric methods have been previously reported for the analysis of fosinopril sodium in simulated salivary fluid (SSF, pH 6.8) and simulated gastric fluid (SGF, pH 1.2). However, researchers favor UV-spectrophotometry due to its versatility, simplicity, and efficiency in drug analysis. Aim: The aim of this study was to develop and validate a simple, rapid, and cost-effective UV-spectrophotometric method for analyzing fosinopril sodium in both experimental and commercial dosage forms, as well as in novel drug delivery systems. Materials and methods: This study presents the development of a UV-spectrophotometric method for quantifying fosinopril sodium in enzyme-free SSF and SGF media and its validation.

Results

Maximum absorbance is observed at 209 nm in SSF and 207 nm in SGF. The technique demonstrates linearity in the range of 2.5–20 μg/mL, with a limit of detection and limit of quantification of 0.0438 μg/mL and 0.133 μg/mL in SSF, and 0.0714 μg/mL and 0.216 μg/mL in SGF, respectively. Analytical recovery is 100.1% in SSF and 99.9% in SGF, with RSD values of 0.373% in SSF and 0.203% in SGF, indicating high precision and accuracy.

Conclusion

These results demonstrate that the developed and validated method is suitable for the routine quantitative determination of fosinopril sodium in experimental and commercial pharmaceutical formulations.