开发高级化学计量学辅助分光光度法测定克仑特罗钠及其碱性降解产物。

Development of Advanced Chemometric-Assisted Spectrophotometric Methods for the Determination of Cromolyn Sodium and Its Alkaline Degradation Products.

机构信息

Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Ain Shams University, Organization of African Unity Street, Abassia, Cairo 11566, Egypt.

Medicinal Chemistry Department, Faculty of Pharmacy, King Salman International University, Ras-Sedr, South Sinai Governorate 46612, Egypt.

出版信息

Molecules. 2020 Dec 16;25(24):5953. doi: 10.3390/molecules25245953.

Advanced and sensitive spectrophotometric and chemometric analytical methods were successfully established for the stability-indicating assay of cromolyn sodium (CS) and its alkaline degradation products (Deg1 and Deg2). Spectrophotometric mean centering ratio spectra method (MCR) and chemometric methods, including principal component regression (PCR) and partial least square (PLS-2) methods, were applied. Peak amplitudes after MCR at 367.8 nm, 373.8 nm and 310.6 nm were used within linear concentration ranges of 2-40 µg mL, 5-40 µg mL and 10-100 µg mL for CS, Deg1 and Deg2, respectively. For PCR and PLS-2 models, a calibration set of eighteen mixtures and a validation set of seven mixtures were built for the simultaneous determination of CS, Deg1 and Deg2 in the ranges of 5-13 µg mL, 8-16 µg mL, and 10-30 µg mL, respectively. The authors emphasize the importance of a stability-indicating strategy for the investigation of pharmaceutical products.

建立了灵敏的分光光度和化学计量学分析方法，用于检测 cromolyn 钠（CS）及其碱性降解产物（Deg1 和 Deg2）的稳定性。应用了分光光度均值中心化比值光谱法（MCR）和化学计量学方法，包括主成分回归（PCR）和偏最小二乘（PLS-2）方法。在 MCR 后，在 367.8nm、373.8nm 和 310.6nm 处的峰幅度分别在 CS、Deg1 和 Deg2 的线性浓度范围内为 2-40μg/mL、5-40μg/mL 和 10-100μg/mL。对于 PCR 和 PLS-2 模型，建立了一个包含十八个混合物的校准集和一个包含七个混合物的验证集，用于同时测定 CS、Deg1 和 Deg2 的浓度范围分别为 5-13μg/mL、8-16μg/mL 和 10-30μg/mL。作者强调了采用稳定性指示策略研究药物产品的重要性。