Innovative Earth-Friendly UV-Spectrophotometric Technique for In Vitro Dissolution Testing of Miconazole Nitrate and Nystatin in Their Vaginal Suppositories: Greenness Assessment.

Background: The combined mixture of miconazole nitrate (MIC) and nystatin (NYS) has proven its efficiency as a prodigious remedy to cure women's frequent infections: vaginal mycosis and vaginal candidiasis.

Objective: A novel green spectrophotometric technique, namely the Fourier self-deconvolution method (FSD), was employed for the quantitative determination of MIC and NYS in their pure and pharmaceutical forms without prior separation. Moreover, the proposed technique was first employed to study the dissolution profile of the cited drugs in their pharmaceutical formulation according to FDA recommendations without excipient interference.

Method: The FSD method is based on a simple mathematical manipulation of zero-order spectra of the cited drugs, which suffered from severe overlapping, so zero-order spectra of the cited drugs were deconvoluted using the Fourier wavelet function in spectrophotometer software. The deconvoluted amplitudes for MIC and NYS were measured at 255 nm and 320 nm, respectively.

Results: Linearity ranges were 70-700 µg/mL for MIC and 1-25 µg/mL for NYS. The greenness of the proposed technique was assessed using two assessment tools, namely eco-scale scoring and green analytical procedure index (GAPI), revealing the excellent greenness of this technique. The proposed technique was validated consistent with ICH guidelines and statistically compared to the reported method with no significant differences between them.

Conclusions: The proposed technique has advantages of being simple, time-saving, and noting need any modification to be suitable for quantitative analysis of MIC and NYS in both pharmaceutical and laboratory mixtures.

Highlights: An innovative FSD method was developed for quantitative analysis of MIC and NYS in their synthetic and pharmaceutical mixtures and applied for in vitro dissolution testing of their pharmaceutical mixture, producing satisfactory results.