Analytical Method for Estimation of Enalapril by UV Spectrophotometry Using Hydrotropic Solubilization: AGREE Metric Evaluation

Objectives

The objective of the current study was to design and confirm a green, eco-friendly UV-visible spectrophotometric system of estimating Enalapril maleate using safe and cost-effective solvents.

Materials and Methods

Several hydrotropic solvents were also screened to improve the solubility of Enalapril and the choice was made on 2 M ammonium acetate, which enhanced the solubility of Enalapril by about 40-fold over distilled water. Its maximum absorbance was registered at 265 nm and was linear at 2-10 ug/mL. The method validation was done according to the ICH guidelines, and the accuracy, precision, sensitivity (LOD and LOQ) and the reliability were evaluated with the help of a marketed formulation (Enam 5 mg). The studies on forced degradation under acidic, basic, neutral, and oxidative environments were conducted to determine stability-indicating character of the method. Method greenness was evaluated using the AGREE software.

Results

The procedure was proven to be very linear, accurate (mean recovery 98.5%) and precise (%RSD < 2%). LOD was 0.70 µg/mL and LOQ 2.11 µg/mL. The tablet analysis of marketed products depicted 101.7% marking the content. Studies about forced degradation showed stability in neutral and basic media, whereby acidic (14.37%) and oxidative (17.35) conditions were observed to undergo degradation. AGREE score of 0.87 showed that there was remarkable observance of the postulates of green analytical chemistry.

Conclusion

The designed UV-visible spectrophotometric system is easily obtained, dependable, specific and sustainable to the environment. It can be used in quality control of Enalapril maleate in bulk drug and pharmaceutical preparations of routine quality control of the substance and in promoting green analytical practice.