Stability-indicating RP-HPLC method for determination of beclomethasone dipropionate in nanocapsule suspensions

Chassot, Janaíne Micheli; Ferreira, Luana Mota; Gomes, Felipe Pereira; Cruz, Letícia; Tasso, Leandro

doi:10.1590/s1984-82502015000400006

Cited by 5 publications

(1 citation statement)

References 16 publications

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“…BDP formulations have already been analysed by various HPLC methods,13 14 which were basically on reversed phase mode with isocratic elution, using water-acetonitrile or water-methanol as mobile phases. BDP assay on reversed phase mode with isocratic elution is also described in Japanese Pharmacopoeia (JP) 17th edition15 and US Pharmacopoeia 16.…”

Section: Resultsmentioning

confidence: 99%

Stability assessment and content determination test of oral liquid forms of beclomethasone dipropionate prepared in hospital pharmacy

Saeki,

Sakamoto,

Saito

et al. 2023

Eur J Hosp Pharm

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ObjectivesOral beclomethasone dipropionate (BDP) is known for its use as a therapeutic medicine for gastrointestinal graft-versus-host disease (GI-GVHD). Despite growing demand for oral BDP formulation, no commercial forms have yet been marketed. Therefore, at the Tokyo Metropolitan Cancer and Infectious Disease Centre Komagome Hospital, pharmacists prepare oral liquid forms of BDP for patients with upper GI-GVHD. This study aims to develop a new high performance liquid chromatography (HPLC) method for measuring BDP in the prepared formulations and assessing its quality.MethodsWe developed a new HPLC method for measuring BDP in prepared formulations validated according to international guidelines. Three types of formulations were prepared and analysed using the validated HPLC method. One contains 1 mg of BDP per 30 mL aqueous solution, and the others using ethanol for preparation contain 1 mg of BDP per 15 mL aqueous solution. For stability assessment, the BDP contents were assayed while formulations were stored in plastic bottles for 8 weeks under two different conditions of 25°C in bright light and 4°C in darkness. A content determination test was also conducted to assess the individual contents of BDP and lot-to-lot variation in dosage units.ResultsA stability test demonstrated that the remaining BDP content after the storage period was greater than 90% of the initial content in almost all samples regardless of storage conditions. A content determination test showed thattwo new ethanol-containing formulations contained about 0.1 mg more BDP than the original ethanol-free formulation and it was close to the target BDP content of 1 mg. Furthermore, new formulations had less lot-to-lot BDP variation in dosage units than the original formulation.ConclusionsA new HPLC method for measuring BDP in prepared formulations was developed and validated. The results of the stability test and content determination test indicated that the newly designed formulations were superior to the conventional formulation.

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Section: Resultsmentioning

confidence: 99%