Abstract
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.
Highlights
Cromolyn sodium (CS), 5,5’-[(2-hydroxytrimethylene)dioxy]bis[4-oxo-4H-1-benzopyran-2-carboxylate], is a chromone derivative possessing two carboxylic groups (Figure 1a)
The MCR method compared to other spectrophotometric derivative methods has the advantage of eliminating derivative steps, and enhances the signal-to-noise-ratio
The results reveal that the MCR method is selective for determination of this limit of quantitation
Summary
Cromolyn sodium (CS), 5,5’-[(2-hydroxytrimethylene)dioxy]bis[4-oxo-4H-1-benzopyran-2-carboxylate], is a chromone derivative possessing two carboxylic groups (Figure 1a). CS inhibits mast cell degranulation and decreases renal cyst disease. It has other effects on specific organs, including the liver [1,2,3]. CS alkaline degradation in alcoholic solution yields Deg2, 4(2-{3-[2-(3-Carboxy-3-oxo-propionyl)-3-hydroxy-phenoxy]-2-hydroxy-propoxy}-6-hydroxy-phenyl)2,4-dioxo-butyric acid tetra-sodium salt (Figure 1c) [9,10]. This degradation involves opening of the γ-pyrone ring of the chromone nucleus and the formation of a bisacetophenone derivative [4,5]. It is useful and practical to assess CS in the presence of its chief degradation products, either or Deg, which would be of great importance in the routine analysis of CS for of 15
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