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

Molecules

MariamM. Tadros¹  NohaM. El Zahar¹  BassamM. Ayoub² 

[1] Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Ain Shams University, Organization of African Unity Street, Abassia, Cairo 11566, Egypt;Pharmaceutical Chemistry Department, Faculty of Pharmacy, The British University in Egypt, El-Sherouk City, Cairo 11837, Egypt;

关键词: cromolyn sodium;    chemometrics;    mean centering ratio spectra;    multivariate calibration;    stability indicating;   

DOI  :  10.3390/molecules25245953

来源: DOAJ

【 摘 要 】

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⁻¹, 5–40 µg mL⁻¹ and 10–100 µg mL⁻¹ 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⁻¹, 8–16 µg mL⁻¹, and 10–30 µg mL⁻¹, respectively. The authors emphasize the importance of a stability-indicating strategy for the investigation of pharmaceutical products.

【 授权许可】

Unknown