Application of multivariate chemometrics tools for spectrophotometric determination of naphazoline HCl, pheniramine maleate and three official impurities in their eye drops.

This work is concerned with exploiting the power of chemometrics in the assay and purity determination of naphazoline HCl (NZ) and pheniramine maleate (PN) in their combined eye drops. Partial least squares (PLS) and artificial neural network (ANN) were the chosen models for that purpose where three selected official impurities, namely; NZ impurity B and PN impurities A and B, were successfully determined. The quantitative determinations of studied components were assessed by percentage recoveries, standard errors of prediction as well as root mean square errors of prediction. The developed models were constructed in the ranges of 5.0-13.0 μg mL ^-1 for NZ, 10.0-60.0 μg mL ^-1 for PN, 1.0-5.0 μg mL ^-1 for NZ impurity B and 2.0-14.0 μg mL ^-1 for two PN impurities. The proposed models could determine NZ and PN with respective detection limits of 0.447 and 1.750 μg mL ^-1 for PLS, and 0.494 and 2.093 μg mL ^-1 for ANN. The two established models were compared favorably with official methods where no significant difference observed.
(© 2023. The Author(s).)