title: Coenzyme Q10 stability in pediatric liquid oral dosage formulations.
abstract: OBJECTIVE, To study the stability of Coenzyme Q10 (CoQ10), used as therapeutic agent in treatment of cardiovascular and mitochondrial diseases, in three liquid formulations: two soybean oil solutions (50 mg/ml), one of them with the addition of vitamin E and an O/W emulsion (20 mg/ml) for pediatric use. Furthermore, optimize and validate a stabilityindicating HPLC method for the analysis of CoQ10 in the studied formulations. METHOD, All samples were stored at 25°C. CoQ10 content of each formulation was analyzed in duplicate using fast microbore high performance liquid chromatography (Micro HPLC) at 0, 3, 6, 15, 30, 60 and 110 days. RESULTS, All formulations stayed stable at 25°C during the 110 days of the study. However, the oil solutions presented greater content variations through all the study period. CONCLUSIONS, The CoQ10 emulsion can be stored for at least 110 days at 25 °C and it has proven to be safer when narrow dose adjustment is required. The proposed analytical method was suitable for the study of stability of different formulations meeting the validation parameters according to international guidelines.
authors: P N
authors: PN
authors: Estévez
authors: V
authors: V
authors: Tripodi
authors: F
authors: F
authors: Buontempo
authors: S
authors: S
authors: Lucangioli
mesh_terms: D000284:Administration, Oral; D002626:Chemistry, Pharmaceutical; D002648:Child; D002851:Chromatography, High Pressure Liquid; D004304:Dosage Forms; D004355:Drug Stability; D004356:Drug Storage; D004655:Emulsions; D006801:Humans; D013024:Soybean Oil; D014451:Ubiquinone / Q000031:analogs & derivatives* / Q000032:analysis; D014815:Vitamins / Q000032:analysis*
chemical_list: D004304:Dosage Forms; D004655:Emulsions; D014815:Vitamins; D014451:Ubiquinone; D013024:Soybean Oil; C024989:coenzyme Q10