Abstract
BackgroundApremilast is phosphodiesterase-4 and an immunomodulating agent used for treatment of refractory psoriatic arthritis.MethodsThe reversed-phase high-performance liquid-chromatography method for analysis of apremilast was developed and validated as per ICH guidelines. The separation of apremilast was performed on PrincetonSPHERE Ultima C18 column (250 mm × 4.6 mm, i.d., 5 μm particle size) with photodiode array detection carried out at 231 nm. A Box–Behnken design with response surface methodology was executed out for optimization of chromatographic conditions of reversed-phase high-performance liquid-chromatography for finished desired chromatographic separation of apremilast from its formulation with less number of experimental trials. Three independent factors, namely methanol composition in the mobile phase, pH of an aqueous phase, and flow rate, were used to construct a mathematical model and study the effects of these independent factors on responses such as retention time, theoretical plates, and tailing factor.ResultsOptimized experimental conditions for proposed work consists of methanol and water, pH 3.50 adjusted with ortho-phosphoric acid (70:30 % v/v) as a mobile phase at a flow rate 1 ml/min with a retention time was found to be 5.15 min. Accuracy study was completed at three different levels and was found in the range of 99.44–101.49%.ConclusionThe 3D response surface graphs revealed that the methanol composition and pH of an aqueous phase were both most stringent factors affecting the responses. Thus, a new, precise, and accurate HPLC method was developed and validated and can be used for regular analysis of apremilast.
Highlights
Apremilast (APL) is a new therapeutic medicinal agent accepted for the management of psoriasis and psoriasis arthritis (Baumer et al 2007; Keating 2017)
Literature survey acknowledged that several analytical methods have been reported for optimization of chromatographic conditions in high-performance liquid-chromatography (HPLC) methods using Box–Behnken design (Gumustas et al 2018; De Almeida Borges et al 2013; Zacharis and Vastardi 2018; Dragomiroiu et al 2015; Awotwe-Otoo et al 2012; Bai et al 2010; Beg et al 2012; Gomes et al 2017; Ihssane et al 2011; Jovanov et al 2015; Mirza and Tan 2001 and Patel et al 2017)
Chemical and reagents Pharmaceutical grade APL was purchased from Sigma-Aldrich (India); High-performance liquidchromatography (HPLC) grade methanol, ortho phosphoric acid and double-distilled water were purchased from Merck (Mumbai, India)
Summary
Apremilast (APL) is a new therapeutic medicinal agent accepted for the management of psoriasis and psoriasis arthritis (Baumer et al 2007; Keating 2017). APL is used as orally administered medicine and acts by inhibiting phosphodiesterase 4, which is inhibited intracellularly and responsible for inflammation by lowering the proportion of cAMP; needful for producing the pro- and. Design of experiments (DOE) has been often executed to optimize analytical methods because of its application, like a decrease in the total number of attempts that need be carried out bringing about less reagent utilization and extensively lower laboratory task. Apremilast is phosphodiesterase-4 and an immunomodulating agent used for treatment of refractory psoriatic arthritis
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