engleski

Influence of coloured additives on photostability of rosuvastatin calcium

Rosuvastatin photostablity stress testing was evaluated. Photodegradation of rosuvastatin in different solvents yielded two main isomeric photoproducts. Photoproducts were isolated by means of preparative column chromatography after rosuvastatin photodegradation on preparative scale and identified by elucidation of 1D and 2D NMR spectra. Photoproducts are result of intramolecular cyclisation reaction followed by 1, 5 hydrogen shift. Solid formulations of rosuvastatin calcium with colored and uncolored additives were made and photostability was examined under long wave UV light. Photodegradation of solid rosuvastatin calcium formulations yielded much smaller amounts of photodegradation products when using coloured additives compared to noncolored additives.

Rosuvastatin calcium; photodegradation; intramolecular cyclization; photoprotection

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