Abstract
In this work, the quantitative determination of an erectile dysfunctional drug avanafil in the presence of its acid-induced degradation product was achieved via the application of a pre-optimized novel spectrofluorimetric method. The fluorescence emission wavelength was recorded at 370 and 407 nm, after being excited at 268 and 271 nm for avanafil and its acid-induced degradation product, respectively. Direct determination of avanafil based on its native fluorescence is restricted because the emission spectra of both components are heavily overlapped. Therefore, to overcome this constraint, a novel second derivative synchronous fluorescence method was evolved to eliminate this overlapping. The ideal determination wavelength was found to be 377 nm. Augmentation of lean six sigma (LSS) with response surface methodology (RSM) play a significant role in the development of robust specifications to ensure quality at the six sigma level with a high level of statistical confidence and targeted performance. All of the experimental conditions were optimized using D-optimal design as a RSM to select the optimal parameters. In addition, this work includes a graphical representation of the relationships between various variables that can greatly affect the results and the intensity of the synchronous fluorescence.
Highlights
Avana l is known chemically as (S)-4-[(3-chloro-4-methoxybenzyl)amino]-2-[2-(hydroxymethyl)-1-pyrrolidinyl]-N-(2pyrimidinylmethyl)-5-pyrimidinecarboxamide (Fig. 1)
Avana l is used for the treatment of erectile dysfunction owing to its inhibiting effect on speci c phosphodiesterase type 5 (PDE5) enzymes present in various body tissues, which are found in the corpus cavernosum in the penis
The tted model was obtained using Design-Expert® trial version 11.0 so ware utilizing a full array of responses
Summary
Avana l is known chemically as (S)-4-[(3-chloro-4-methoxybenzyl)amino]-2-[2-(hydroxymethyl)-1-pyrrolidinyl]-N-(2pyrimidinylmethyl)-5-pyrimidinecarboxamide (Fig. 1). It is a white crystalline powder, with the molecular formula C23H26ClN7O3 and a molecular weight of 483.95. It is soluble in 0.1 M hydrochloric acid, practically insoluble in water and slightly soluble in ethanol. Avana l is used for the treatment of erectile dysfunction owing to its inhibiting effect on speci c phosphodiesterase type 5 (PDE5) enzymes present in various body tissues, which are found in the corpus cavernosum in the penis. In spite of these side effects, its use is still preference over the other PDE5 drugs.[1,2,3,4,5] For the determination of avana l, the literature reveals that many methods have been reported for the quantitative estimation of the studied drug avana l including multivariate chemometric methods[6] and different chromatography techniques.[7,8,9,10,11,12]
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