Stability study of amiodarone hydrochloride in capsules for paediatric patients using a high-performance liquid chromatography method

Beyond-Use Dates Assignment for Pharmaceutical Preparations: Example of Low-Dose Amiodarone Capsules

“…Two other studies showed experimental degradations with acid and alkaline conditions but did not report the percentage of amiodarone degradation. 9,25 The most recent work was centered on a detailed forced degradation study, and has results consistent with our findings, although the authors have observed amiodarone degradation under strong oxidative conditions (H 2 O 2 30%). 27 In this study, authors reported the percentage of amiodarone degradation in correct proportions (about 10% to 30%).…”

“…Forced degradation studies of amiodarone hydrochloride were previously described in the literature. 9,24-27 Two studies did not notice any degradation under most of the experimental conditions except light and acid. 24-26 The degradation products were not detailed in these publications.…”

“…Mannitol is a widely used diluent, and its use for amiodarone capsules compounding has already been studied. 9 Ten milligrams, 60 mg, and 100 mg amiodarone capsules were stable for 1 year when stored at ambient temperature.…”

Evaluation of pharmacokinetics and the stability of daptomycin in serum at various temperatures

“…Temperature frequently affects drug stability. [18][19][20][21] Sader et al reported that the concentrations of imipenem, meropenem, and doripenem in normal saline stored at 30-40 C decreased by more than 10% over 24 h. 21 It is important to elucidate the effects of temperature on drug stability for sample storage and the precise measurement of blood concentrations. Therefore, the long-term stability of daptomycin in serum was evaluated in the present study.…”

Physicochemical Compatibility of Amiodarone with Parenteral Nutrition

“…Regarding the chemical stability assessment, we performed an HPLC analysis (HP 1100 HPLC; Scientific Services, University of Barcelona, Barcelona, Spain) on the final samples to determine amiodarone concentration and confirm the lack of degradation products. The HPLC method performed was that adapted by Rughoo et al from an analytical method previously reported by Martín‐Algarra et al . The system consisted of a Spectra‐Physics Analytical HPLC chain characterized by a P2000 solvent delivery system, an AS1000 automatic injection device, a UV2000 programmable wavelength detector operating at 242 nm, and an SN4000 integrator, all managed by a personal computer with ChromQuest software (Thermo Fisher, Villebon sur Yvette, France).…”