Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr el Aini Street, Cairo, 11562, Egypt.
Analytical Chemistry Department, Faculty of Pharmacy, Modern University for Technology and Information, El-Hadaba El-Wosta, Mokatam, 5th District, Cairo, Egypt.
Sci Rep. 2023 Nov 11;13(1):19678. doi: 10.1038/s41598-023-46940-0.
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 for NZ, 10.0-60.0 μg mL for PN, 1.0-5.0 μg mL for NZ impurity B and 2.0-14.0 μg mL for two PN impurities. The proposed models could determine NZ and PN with respective detection limits of 0.447 and 1.750 μg mL for PLS, and 0.494 and 2.093 μg mL for ANN. The two established models were compared favorably with official methods where no significant difference observed.
这项工作致力于利用化学计量学的力量来测定复方盐酸萘甲唑啉滴眼液中盐酸萘甲唑啉（NZ）和马来酸苯吡胺（PN）的含量和纯度。为此，选择了偏最小二乘法（PLS）和人工神经网络（ANN）作为模型，成功地测定了三种选定的官方杂质，即 NZ 杂质 B 和 PN 杂质 A 和 B。通过百分比回收率、预测标准误差和预测均方根误差评估了所研究成分的定量测定。所建立的模型在 NZ 的浓度范围为 5.0-13.0μg/mL、PN 的浓度范围为 10.0-60.0μg/mL、NZ 杂质 B 的浓度范围为 1.0-5.0μg/mL 以及两种 PN 杂质的浓度范围为 2.0-14.0μg/mL。所提出的模型可以用 PLS 法分别测定 NZ 和 PN 的检测限为 0.447μg/mL 和 1.750μg/mL，用 ANN 法分别测定 NZ 和 PN 的检测限为 0.494μg/mL 和 2.093μg/mL。这两个建立的模型与官方方法进行了有利的比较，没有观察到显著差异。
