Accelerated chemical stability data of O/W fluid emulsions containing the extract of Trichilia catigua Adr. Juss (and) Ptychopetalum olacoides Bentham

Abstract

Development of topical dosage forms requires physical, physicochemical and chemical assays that provide, as soon as possible, the formulation with the best stability profiles. This study evaluated the stability of O/W fluid emulsions, by total flavonoids determination, expressed in rutin, containing the standardized extract of Trichilia catigua Adr. Juss (and) Ptychopetalum olacoides Bentham. Samples were evaluated for 90 days stored at 24.0 ± 2.0°C, 5.0 ± 0.5°C and 40.0 ± 0.5°C, following a protocol for the assessment of accelerated chemical stability assay, also known as Normal Stability Test. A sensitive UV-spectrophotometric method at 361.0 nm was previously validated for the determination of the active substance. By Normal Stability Test, the O/W fluid emulsions presented acceptable chemical stability, for at least 90 days, when the samples were stored at 24.0 ± 2.0°C and 5.0 ± 0.5°C. The storage condition at 40.0 ± 0.5°C has accelerated the degradation process of the total flavonoids, consequently, those O/W emulsions containing this kind of natural active substance or a similar preparation must not be stored at elevated temperatures.