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

Abstract

A simple stability-indicating RP-HPLC/UV method was validated for determination of beclomethasone dipropionate (BD) in nanocapsule suspensions. Chromatographic conditions consisted of a RP C 18 column (250 mm x 4.60 mm, 5 µm, 110 Å), using methanol and water (85:15 v/v) as mobile phase at 1.0 mL/ min with UV detection at 254 nm. The calibration curve was found to be linear in the concentration range of 5.0-25.0 µg/mL with a correlation coefficient > 0.999. Precision was demonstrated by a relative standard deviation lower than 2.0%. Accuracy was assessed by the recovery test of BD from nanocapsules (98.03% to 100.35%). Specificity showed no interference from the components of nanocapsules or from the degradation products derived from acid, basic and photolytic conditions. In conclusion, the method is suitable to be applied to assay BD in bulk drug and in nanocapsules, and it can be employed to study stability and degradation kinetics.Uniterms: High performance liquid chromatography/reverse phase/quantitative analysis. Beclomethasone dipropionate/determination. Nanocapsule/suspensions. Nanoparticles.Um método simples de CLAE-FR/UV indicativo de estabilidade foi validado para a determinação do dipropionato de beclometasona (BD) em suspensões de nanocápsulas. As condições cromatográficas foram: coluna C18 fase reversa (250 mm x 4,60 mm, 5 µm, 110 Å), usando como fase móvel metanol e água (85:15 v/v) a 1,0 mL/min, com detecção UV a 254 nm. A curva de calibração foi linear no intervalo de 5,0-25,0 µg/mL com coeficiente de correlação >0,999. A precisão foi demonstrada por um desvio padrão relativo menor que 2,0%. A exatidão foi avaliada pelo teste de recuperação do BD a partir das nanocápsulas (98,03% a 100,35%). O teste de especificidade não mostrou interferência dos componentes das nanocápsulas e nem dos produtos de degradação derivados de condições ácidas, básicas e fotolíticas. Em conclusão, o método é adequado para ser aplicado na avaliação do BD puro e em nanocápsulas e pode ser empregado para o estudo de estabilidade e degradação cinética.Unitermos: Cromatografia líquida de alta eficiência/fase reversa/análise quantitativa. Dipropionato de beclometasona/determinação. Nanocápsulas/suspensões. Nanopartículas.

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

“…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.…”

Development and Validation of Novel Rp-HPLC Method for the Simultaneous Estimation of Salicylic Acid and Beclomethasone Dipropionate in a Topical Ointment Dosage Form

“…The mechanism of action of BD is observed at the level of the cell nucleus, which interacts with DNA and consequently stimulates or inhibits gene transcription. This drug acts as a transcription factor that alters the expression of target genes in response to a specific hormonal signal [3]. SA is a beta-hydroxy acid, a monohydroxybenzoic acid, and a subclass of phenolic acid [4].…”