Lotfy, H. M., S. S. Saleh, Y. Rostom, R. H. Obaydo, and D. A. Ahmed, "Advanced Approaches in Green Univariate Spectrophotometric Methods", Sustainable Approaches in Pharmaceutical Sciences, pp. 157–215: Wiley , 2023.
Saleh, S. S., R. H. Obaydo, M. A. El Hamd, Y. Rostom, D. Mohamed, and H. M. Lotfy, "Guidelines for accurate application of green and white analytical concepts: Merits Versus demerits with insights of significant milestones of assessment tools applied for antiviral drugs", Microchemical Journal , vol. 199, pp. 109917, 2024.
Rostom, Y., O. G. Hussein, M. A. Kawy, M. R. Rezk, and D. A. Ahmed, "A Novel Spectrofluorimetric Determination of Antazoline and Xylometazoline in their Ophthalmic Formulation; Green Approach and Evaluation.", Journal of fluorescence, 2024. Abstract

A green developed spectrofluorimetric method has been applied for Antazoline (ANT) and Xylometazoline (XLO) determination in both pharmaceutical formulation and pure form. The developed method is synchronous spectrofluorimetry coupled with the second derivative mathematical tool for the determination of antazoline and xylometazoline in their dosage form. The developed method depends on reacting the cited drugs with dansyl chloride, a suitable derivatizing agent, to generate highly fluorescent derivatives. The products formed were measured at emission wavelengths; 703.0 and 712.0 nm after being excited at wavelengths; 350.0 and 355.0 nm for antazoline and xylometazoline, respectively. Synchronous spectrofluorimetry coupled with second derivative mathematical tool was developed and optimized using fluorescence data manager software generating second derivative peak amplitudes at 556.5 nm for antazoline and 598.0 nm for xylometazoline. Linear responses have been represented over a wide range of concentration 0.5-12.0 µg/mL for antazoline and 0.1-10.0 µg/mL for xylometazoline, correspondingly. Method validation was successfully applied. Additionally, statistical comparison of developed method with official ones has been carried out where no significant difference was found. Evaluation of the method's greenness was proven using several assessment tools. Indeed, the method developed is found to be precise, sensitive, and discriminating to assess the cited drugs for regular analysis.

Rostom, Y., M. R. Rezk, M. Wadie, E. M. Abdel-Moety, and H. M. Marzouk, "State-of-the-art mathematically induced filtration approaches for smart spectrophotometric assessment of silodosin and solifenacin mixture in their new challenging formulation: Multi-tool greenness and whiteness evaluation.", Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy, vol. 307, pp. 123650, 2024. Abstract

Benign prostatic hyperplasia is one of the most predominant health disorders in men with increasing incidence by age and usually accompanied with other bothersome symptoms. A new fixed dose combination, containing Silodosin and Solifenacin, has been recently launched for relieving such disorder associated with overactive bladder syndrome. In the current work, three smart, innovative and white spectrophotometric methods have been newly developed and optimized for simultaneous determination of the studied drugs in their binary mixture using water as an eco-friendly solvent. The adopted strategy relied on calculation of one or two factors as numerical constant or spectrum allowing mathematical filtration of desired analyte and full removal of any overlapped components in the mixture. The developed methods are categorized over two spectrophotometric platform windows. Window I deals with absorption spectra in its native forms (zero-order) including a newly developed method termed induced concentration subtraction (ICS) as well as induced dual wavelength (IDW) methods. Whereas window III is concerned with ratio spectra as in induced amplitude modulation (IAM) method. Compared to classical spectrophotometric methods, the proposed ones are superior in overcoming the inherited challenges in zero-order absorption spectrum of Solifenacin, particularly its very low absorptivity and lack of unique absorption maximum. Validity of the methods were thoroughly assured as per ICH guidelines with unified regression over 3.0-50.0 µg/mL in ICS method while IDW and IAM ones possessed linearity ranges of 3.0-50.0 µg/mL of Silodosin and 5.0-60.0 µg/mL of Solifenacin. The work was also extended to verify content uniformity of dosage units in accordance with USP recommendations. Greenness profile of the proposed methods was clearly assessed, in comparison to the reported analysis ones, via state-of-the-art software metrics, namely, green solvent selection tool (GSST), complementary green analytical procedure index (ComplexGAPI) and analytical greenness (AGREE). Finally, the proposed methods were in good adherence to the recently published postulates of white analytical chemistry.

Hussein, O. G., D. A. Ahmed, M. R. Rezk, M. A. Kawy, and Y. Rostom, "Exquisite integration of quality-by-design and green analytical approaches for simultaneous determination of xylometazoline and antazoline in eye drops and rabbit aqueous humor, application to stability study.", Journal of pharmaceutical and biomedical analysis, vol. 235, pp. 115598, 2023. Abstract

This work implements a stability indicating HPLC method developed to simultaneously determine xylometazoline (XYLO) and antazoline (ANT) in their binary mixture, rabbit aqueous humor and cited drug's degradates by applying analytical quality-by-design (AQbD) combined with green analytical chemistry (GAC) experiment for the first time. This integration was designed to maximize efficiency and minimize environmental impacts, as well as energy and solvent consumption. Analytical quality-by-design was applied to achieve our aim starting with evaluation of quality risk and scouting analysis, tracked via five parameters chromatographic screening using Placket-Burman design namely: pH, temperature, organic solvent percentage, flow rate, and wavelength detection. Recognizing the critical method parameters was done followed by optimization employing central composite design and Derringer's desirability toward assess optimum conditions that attained best resolution with satisfactory peak symmetry with short run time. Optimal chromatographic separation was attained by means of an XBridge® C18 (4.6 × 250 mm, 5 µm) column through isocratic elution using a mobile phase consists of phosphate buffer (pH 3.0): ethanol (60:40, by volume) at a 1.6 mL/min flow rate and 230.0 nm UV detection. Linearity acquired over a concentration range of 1.0-100.0 µg/mL and 0.5-100.0 µg/mL for XYLO and ANT, respectively. Furthermore, imperiling cited drugs' stock solutions to stress various conditions and satisfactory peaks of degradation products were obtained indicating that cited drugs are vulnerable to oxidative degradation and basic hydrolysis. Degradates' structures were elucidated using mass spectrometry. Applying various assessment tools; namely: analytical greenness (AGREE), green analytical procedure index (GAPI), analytical eco-scale, and national environmental method index (NEMI), Greenness method's evaluation was applied and proved to be green. In fact, the developed method is established to be perceptive, accurate, and selective to assess cited drugs for routine analysis.

Hussein, O. G., D. A. Ahmed, M. A. Kawy, M. R. Rezk, and Y. Rostom, "A novel green spectrofluorimetric method for simultaneous determination of antazoline and tetryzoline in their ophthalmic formulation.", Luminescence : the journal of biological and chemical luminescence, vol. 39, issue 3, pp. e4728, 2024. Abstract

A novel spectrofluorimetric method has been developed for determination of antazoline (ANT) and tetryzoline (TET) in their pharmaceutical formulation. A combined application of synchronous spectrofluorimetry and second derivative mathematical treatment was developed. The proposed method depends on reacting the cited drugs with dansyl chloride (DNS-Cl) being a suitable derivatizing agent generating highly fluorescent derivatives measured at emission wavelengths of 703.0 and 642.0 nm after excitation wavelengths of 350.0 and 320.0 nm for ANT and TET, respectively. The joint use of synchronous spectrofluorimetry with second derivative mathematical treatment is for the first time to be developed and optimized in aid of using fluorescence data manager software generating second derivative peak amplitudes at 556.5 nm for ANT and 516.7 nm for TET. Linear responses have been represented over a wide range of concentration (0.5-12.0 μg/mL for ANT and 0.5-10.0 μg/mL for TET). Additionally, statistical comparison of the developed method with the official ones has been carried out where no significant difference was found. Additionally, greenness profile assessment was accomplished by means of four metric tools. Indeed, the method developed is found to be precise, sensitive, and discriminating to assess the cited drugs for regular analysis.

Sami, I., Y. Rostom, H. H. Monir, and Y. S. El-Saharty, "Sustainable spectrophotometric resolution techniques for a spectrally overlapping mixture of Articaine Hydrochloride and Epinephrine Bitartrate with challenging formulation ratio", Sustainable Chemistry and Pharmacy, vol. 32, pp. 100994, 2023.
Soliman, R. M., Y. Rostom, A. M. Mahmoud, Y. M. Fayez, N. M. Mostafa, and H. H. Monir, "Novel fabricated potentiometric sensors for selective determination of carbinoxamine with different greenness evaluation perspectives", Microchemical Journal , vol. 187, pp. 108381, 2023.
Hussein, O. G., M. A. Kawy, M. R. Rezk, D. A. Ahmed, and Y. Rostom, "Novel Stability-Indicating TLC-Densitometric Method for Quantification of Antazoline and Tetryzoline; Application to Pharmaceutical Formulation", Results in Chemistry, vol. 5, pp. 100920, 2023.
Hussein, O. G., Y. Rostom, M. A. Kawy, M. R. Rezk, and D. A. Ahmed, "Spectrophotometric platform windows' exploitation for the green determination of Alcaftadine in presence of its oxidative degradation product.", Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy, vol. 297, pp. 122737, 2023. Abstract

This study presents the determination of Alcaftadine (ALF) in its oxidative degradation product presence by applying comprehensive study comparative of four different green stability indicating spectrophotometric approaches through successful exploitation of different spectrophotometric platform windows. Window I; based on absorption spectrum zero order data manipulation using the newly developed extended absorbance difference (EAD). Window II; based on derivative spectra by second order derivative (D) data manipulation. Window III; based on ratio spectra applying constant multiplication (CM) and absorptivity centering via factorized ratio difference spectrum (ACT-FSR) methods data manipulation. Finally, window IV; based on derivative of ratio spectrum by virtue of first derivative of ratio spectral (DD) method data manipulation. Calibration curves construction were over linearity range; 1.0-14.0 µg/mL for ALF. The proposed methods accuracy, precision, and linearity range were determined and validated as per ICH guidelines. Moreover, they were able to analyze ALF in raw form, dosage form and in existence of its oxidative degradation product. Statistical comparisons were done between the proposed methods and the reported one showing no significant difference concerning accuracy and precision. Furthermore, greenness profile assessment was accomplished by means of four metric tools; namely: analytical greenness (AGREE), green analytical procedure index (GAPI), analytical eco-scale, and national environmental method index (NEMI).

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