Hesham Salem

Two simple, sensitive, and eco-friendly spectroscopic methods were developed for the determination of ensartinib through ion-pair complexation with eosin Y. Method A represents the first reported spectrofluorometric assay for the studied drug and it is based on fluorescence quenching of eosin Y at pH 3.3, showing linearity over 100–1000 ng mL⁻¹ with LOD and LOQ values of 21.2 and 64.1 ng mL⁻¹, respectively. Method B is a spectrophotometric method based on measuring the absorbance of the formed ion-pair complex at 550 nm, obeying Beer’s law over 1.0–10.0 µg mL⁻¹, with LOD and LOQ values of 132 and 400 ng mL⁻¹, respectively. Both methods were validated according to ICH guidelines and exhibited excellent accuracy (98.51–101.68%) and precision (RSD < 2%). The proposed procedures were successfully applied to capsules, providing mean recoveries of 99.29 ± 1.11% and 100.39 ± 0.98% for Methods A and B, respectively. Statistical comparison with a reported chromatographic method showed no significant difference at the 95% confidence level. The environmental impact of the developed methods was assessed using AGREE and GAPI tools, confirming their compliance with green analytical chemistry principles.

Two green analytical procedures were designed to quantify terlipressin in bulk material and pharmaceutical dosage forms. In both procedures, terlipressin interacts with Eosin Y through ion‐pair formation between the drug's protonated amino group and the anionic dye under controlled experimental settings. In the fluorimetric procedure, the resulting complex suppresses the native fluorescence of Eosin Y. Measurements are carried out in acetate buffer (pH 3.3), where the decrease in fluorescence is directly related to terlipressin concentration across 50–500 ng/mL. In the spectrophotometric procedure, the ion‐pair complex is quantified by measuring absorbance at 550 nm, providing a linear response over 1–10 μg/mL. Both methods were validated and found to meet international analytical guidelines for linearity, accuracy, precision, and robustness. Their environmental impact was also evaluated using established “greenness” assessment tools, and the results showed good ecological performance because the procedures mainly use aqueous solutions. Overall, these methods are simple and inexpensive options for routine quality control of terlipressin, offering practical alternatives to more complex chromatographic techniques.

A novel, eco-friendly spectrofluorimetric method has been developed for the sensitive determination of capivasertib, based on resonance Rayleigh scattering enhancement. Unlike previously reported methods, this approach utilizes erythrosine B as a safer ion-pairing reagent in an acidic aqueous medium, eliminating the need for organic solvents or complex extraction steps. The interaction between capivasertib and erythrosine B leads to a stable ion-pair complex, producing a strong Rayleigh scattering signal measurable at λex530/λem550 nm. The method demonstrated excellent linearity over the range of 20–2000 ng mL⁻¹, with a detection limit of 5.61 ng mL⁻¹ and a quantification limit of 17 ng mL⁻¹. All analytical parameters were optimized and validated according to ICH guidelines. To holistically substantiate sustainability, the method’s environmental and practical profiles were appraised using all contemporary greenness/whiteness/applicability metrics employed in this work: Analytical Eco-Scale (ESA), NEMI pictogram, GAPI, AGREE, and AGREE-prep for sample-preparation greenness; the White Analytical Chemistry RGB12 model (whiteness); and the Blue Applicability Grade Index (BAGI) (blueness/applicability). This work introduces a greener, simpler, and more accessible alternative for capivasertib analysis, with potential applications in pharmaceutical quality control and routine laboratory testing.

A novel, simple and highly sensitive spectrofluorimetric approach has been developed and validated for the first time for determination of berotralstat through derivatization reaction using fluorescamine as a fluorescent probe. The reaction was carried out in buffered medium at pH 7.5, using a borate buffer. After being illuminated at 390 nm, the fluorescence intensity of the resulting product was measured at 480 nm. The proposed approach demonstrated linearity within the concentration range of 100 to 1000 ng mL ^− 1 . LOD and LOQ are 6.98 and 26.36 ng mL ^− 1 , respectively. Pharmaceutical capsules of berotralstat were successfully evaluated in addition to spiked biological fluid. The statistical data has been validated in accordance with ICH criteria. Additionally, it was applied to examine the content uniformity in accordance with US Pharmacopeia requirements. Furthermore, the results of the ecology scale scores indicated that the analytical process involved was green.

In order to determine the appropriate dosage of pirtobrutinib for treating mantle cell lymphoma that has returned or has not responded to prior treatment, a novel, straightforward, sensitive, and quick first spectrofluorometric approach has been devised. The technique uses 2% w/v sodium dodecyl sulfate (SDS) as an anionic surfactant to micellarly increase the drug’s natural fluorescence. Following excitation at 320 nm, the increased fluorescence intensity of pirtobrutinib was observed at 380 nm. An assay method for determining the researched drug was developed by analyzing the drug’s interaction with SDS and taking advantage of the increased fluorescence intensity. With a detection limit of 8.66 ng mL ^− 1 and a quantitation limit of 26.23 ng mL ^− 1 , the relative fluorescence intensity-concentration graphs were rectilinear for the 30–1000 ng mL ^− 1 range. The results of the validation of the proposed analytical method in compliance with ICH standards were judged to be satisfactory. The suggested technique was effectively used for detection in tampered-with human plasma and pharmaceutical formulation. A number of assessment tools have lately been presented, as GAPI and AGREE.

This study demonstrates the creation and verification of a selective and sensitive spectrofluorometric approach for the quantification of lefamulin via its reaction at pH 7.5 with fluorescamine, utilizing borate buffer to yield a highly luminous result. The fluorescence intensity of the resultant product was quantified at 480 nm following illumination at 390 nm. The experimental variables affecting the production, stability, and fluorescence intensity of the resultant product were examined and optimized. The proposed approach demonstrated linearity within the concentration range of 50 to 1500 ng/mL; 48.57 and 16.03 ng/mL were the quantitation and detection limits, respectively. Pharmaceutical tablets of lefamulin were successfully evaluated in dosage form and spiked biological fluid, and the suggested approach has been validated in accordance with the International Council for Harmonization (ICH) criteria. Additionally, the approach was used to examine the content uniformity in accordance with US Pharmacopeia requirements. Furthermore, the results of the ecology scale scores indicated that the analytical process involved was green.

In order to determine the appropriate dosage of pirtobrutinib for treating mantle cell lymphoma that has returned or has not responded to prior treatment, a novel, straightforward, sensitive, and quick first spectrofluorometric approach has been devised. The technique uses 2% w/v sodium dodecyl sulfate (SDS) as an anionic surfactant to micellarly increase the drug's natural fluorescence. Following excitation at 320 nm, the increased fluorescence intensity of pirtobrutinib was observed at 380 nm. An assay method for determining the researched drug was developed by analyzing the drug's interaction with SDS and taking advantage of the increased fluorescence intensity. With a detection limit of 8.66 ng mL ^− 1 and a quantitation limit of 26.23 ng mL ^− 1 , the relative fluorescence intensity-concentration graphs were rectilinear for the 30–1000 ng mL ^− 1 range. The results of the validation of the proposed analytical method in compliance with ICH standards were judged to be satisfactory. The suggested technique was effectively used for detection in tampered-with human plasma and pharmaceutical formulation. A number of assessment tools have lately been presented, as GAPI and AGREE.