Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, University of Alexandria, Alexandria, Egypt.
Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, University of Alexandria, Alexandria, Egypt; Department of Analytical and Pharmaceutical Chemistry, Faculty of Pharmacy and Drug Manufacturing, Pharos University in Alexandria, Alexandria, Egypt.
Spectrochim Acta A Mol Biomol Spectrosc. 2018 Jun 15;199:328-339. doi: 10.1016/j.saa.2018.03.059. Epub 2018 Mar 27.
A green, simple and cost effective chemometric UV-Vis spectrophotometric method has been developed and validated for correcting interferences that arise during conducting biowaiver studies. Chemometric manipulation has been done for enhancing the results of direct absorbance, resulting from very low concentrations (high incidence of background noise interference) of earlier points in the dissolution timing in case of dissolution profile using first and second derivative (D1 & D2) methods and their corresponding Fourier function convoluted methods (D1/FF& D2/FF). The method applied for biowaiver study of Donepezil Hydrochloride (DH) as a representative model was done by comparing two different dosage forms containing 5mg DH per tablet as an application of a developed chemometric method for correcting interferences as well as for the assay and dissolution testing in its tablet dosage form. The results showed that first derivative technique can be used for enhancement of the data in case of low concentration range of DH (1-8μgmL) in the three different pH dissolution media which were used to estimate the low drug concentrations dissolved at the early points in the biowaiver study. Furthermore, the results showed similarity in phosphate buffer pH6.8 and dissimilarity in the other 2pH media. The method was validated according to ICH guidelines and USP monograph for both assays (HCl of pH1.2) and dissolution study in 3pH media (HCl of pH1.2, acetate buffer of pH4.5 and phosphate buffer of pH6.8). Finally, the assessment of the method greenness was done using two different assessment techniques: National Environmental Method Index label and Eco scale methods. Both techniques ascertained the greenness of the proposed method.
一种绿色、简单且经济高效的化学计量 UV-Vis 分光光度法已经开发并验证，用于校正生物豁免研究中出现的干扰。通过化学计量学处理，增强了直接吸光度的结果，这是由于在使用一阶和二阶导数（D1 和 D2）方法及其相应的傅里叶函数卷积方法（D1/FF 和 D2/FF）进行溶解曲线时，早期点的非常低浓度（高背景噪声干扰发生率）所导致的。应用于盐酸多奈哌齐（DH）的生物豁免研究的方法是通过比较两种不同的片剂制剂来完成的，每种制剂含有 5mg DH，作为开发的化学计量学方法用于校正干扰以及其片剂制剂的含量测定和溶出度测试的应用。结果表明，一阶导数技术可用于增强 DH 低浓度范围（1-8μgmL）的数据分析，在三种不同的 pH 溶解介质中，用于估计在生物豁免研究早期点溶解的低药物浓度。此外，结果表明在磷酸盐缓冲液 pH6.8 中相似，而在另外 2pH 介质中不相似。该方法根据 ICH 指南和 USP 专论进行了验证，包括两种测定方法（pH1.2 的 HCl）和三种 pH 介质（pH1.2 的 HCl、pH4.5 的醋酸盐缓冲液和 pH6.8 的磷酸盐缓冲液）的溶出度研究。最后，使用两种不同的评估技术：国家环境方法索引标签和生态规模方法对方法的绿色度进行了评估。两种技术都证实了所提出方法的绿色性。
