Development and validation of colorimetric method for the determination of aminocaproic acid in bulk and pharmaceutical formulation

Abstract

Objectives: The aim of this work was to develop a simple, accurate and feasible colorimetric method for the analysis of aminocaproic acid (ACA) in bulk and pharmaceutical formulations. Method: The method was based on the coupling of ACA with sodium nitropurrside (SNP) to give a colored product having maximum absorption at 540 nm. The conditions affecting the reaction (SNP concentration, pH, color-developing time, temperature, and dilutent solvent) were investigated. Results: Under the optimum conditions, good linear relationship (r = 0.9986) was obtained between 0.2-1.0 mg/ml. The limits of detection and quantification were 0.07 mg/mL and 0.26mg/mL, respectively. The percentage recovery for the commercial preparation (Aminocaproic acid injection, 250 mg/ ml) was 100.60 ± 2.05 %, (n=3) which reflected no interference by the injection excipients. Based on the molar ratio, the reaction stoichiometry was found to be 2:1. Conclusion: The developed method was validated according to ICH guidelines and proved to be accurate and precise.