Sustainable UV approaches backed by one step extraction procedure for quantifying the newly released mirabegron and silodosin mixture in urine

Abstract

Mirabegron (MIR) and silodosin (SIL) have recently been combined in a single pill to significantly enhance the effectiveness of treating detrusor hyperactivity with impaired contractility (DHIC), leading to appreciable improvements in symptoms associated with overactive bladder. Additionally, this combination effectively manages lower ureteric stones and improves patient outcomes with no significant side effects, especially in elderly patients. Accordingly, this study introduces two UV techniques for analyzing MIR and SIL in their mixtures (pure and commercial mixtures). These techniques were backed by a one-step salting-out liquid/liquid extraction (SALLE) procedure for quantifying MIR and SIL in urine samples without matrix interference. The proposed UV techniques succeeded in resolving the superimposed MIR's and SIL's UV spectra by employing straightforward mathematical filtration. The UV techniques were Fourier self-deconvolution (FSD) and induced dual-wavelength (IDW) techniques, with linearities of (50-350) µg/mL for MIR and (5-100) µg/mL for SIL. The applied techniques were verified following the International Council for Harmonisation (ICH) directives and were statistically evaluated against the published technique, with no noteworthy differences found. The applied techniques' practicality (blueness), whiteness, and greenness were appraised utilizing various metrics. Per the preceding, the applied approaches have been proven to be sustainable, delicate, and appropriate for quality control (QC) testing. Also, backing the applied approaches with the SALLE procedure enables precise monitoring of MIR and SIL in miscellaneous biological fluids with excellent recoveries, presenting an inventive approach for further bioanalytical applications.

Keywords: Fourier self-deconvolution; Induced dual-wavelength; Mirabegron; SALLE; Silodosin.

Fig. 1

Chemical structures of (a) SIL and (b) MIR.

Fig. 2

Zero-order absorption spectra of 250 µg/mL MIR (green spectrum) overlaid with 40 µg/mL SIL (blue spectrum) and their mix (dotted spectrum) using ethanol as a blank.

Fig. 3

The chosen wavelengths for determination of (a) MIR (250 µg/mL) and (b) SIL (40 µg/mL) by the IDW technique.

Fig. 4

Deconvoluted spectra of (a) MIR (50–350) µg/mL computed at 254 nm, where a zero-crossing point of SIL deconvoluted spectrum (dotted spectrum) and (b) SIL (5–100) µg/mL computed at 273 nm, where no intrusion from MIR deconvoluted spectrum (dotted spectrum).

Fig. 5

Deconvoluted spectra of (a) MIR (60–300) µg/mL in urine (computed at 254 nm) and (b) SIL (10–50) µg/mL in urine (computed at 273 nm), where no intrusion from the blank urine deconvoluted spectrum (dotted spectrum).

Fig. 6

Whiteness evaluation of the suggested and reported⁻ techniques by the RGB12 model.

Fig. 7

Blueness assessment of the suggested techniques by the BAGI tool.