article · Molecules
Dacomitinib is an approved targeted therapy for non-small cell lung cancer, but it lacks natural fluorescent properties, making standard optical detection difficult. To address this, a green spectrofluorimetric detection method was developed using newly synthesised nitrogen-doped carbon quantum dots. The quantum dots were produced using microwave heating with orange juice as the carbon source and urea as the nitrogen source, yielding spherical nanoparticles with strong fluorescence and a quantum yield of 25.3 percent. Adding dacomitinib selectively and quantitatively quenches this fluorescence through a static mechanism alongside an inner filter effect. The method operates in water without requiring pre-treatment steps, achieving a linear detection range of 1.0 to 20.0 micrograms per millilitre and a detection limit of 0.11 micrograms per millilitre. Testing adhered to international validation standards and was confirmed on commercial tablets.
Dacomitinib is an essential first-line drug for specific lung cancer mutations, but testing its purity and dosage is challenging because the molecule does not fluoresce naturally. This research introduces a sensitive, non-toxic analytical technique that uses sustainable ingredients rather than hazardous chemicals. It provides a practical and environmentally friendly approach for ensuring drug quality and consistency in cancer care.
This technique offers an applied testing tool for pharmaceutical manufacturers and quality control laboratories assessing dacomitinib formulations. The use of accessible starting materials and water as a solvent could reduce analytical testing costs compared to complex chromatographic methods. Having been applied and tested on commercial Vizimpro tablets in accordance with international validation standards, the protocol is close to routine adoption for pharmaceutical quality control.
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One of the most promising drugs recently approved for the treatment of various types of cancer is dacomitinib, which belongs to the tyrosine kinase inhibitor class. The US Food and Drugs Administration (FDA) has recently approved dacomitinib as a first-line treatment for patients suffering from non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations. The current study proposes the design of a novel spectrofluorimetric method for determining dacomitinib based on newly synthesized nitrogen-doped carbon quantum dots (N-CQDs) as fluorescent probes. The proposed method is simple and does not require pretreatment or preliminary procedures. Since the studied drug does not have any fluorescent properties, the importance of the current study is magnified. When excited at 325 nm, N-CQDs exhibited native fluorescence at 417 nm, which was quantitatively and selectively quenched by the increasing concentrations of dacomitinib. The developed method involved the simple and green microwave-assisted synthesis of N-CQDs, using orange juice as a carbon source and urea as a nitrogen source. The characterization of the prepared quantum dots was performed using different spectroscopic and microscopic techniques. The synthesized dots had consistently spherical shapes and a narrow size distribution and demonstrated optimal characteristics, including a high stability and a high fluorescence quantum yield (25.3%). When assessing the effectiveness of the proposed method, several optimization factors were considered. The experiments demonstrated highly linear quenching behavior across the concentration range of 1.0-20.0 μg/mL with a correlation coefficient (r) of 0.999. The recovery percentages were found to be in the range of 98.50-100.83% and the corresponding relative standard deviation (%RSD) was 0.984. The proposed method was shown to be highly sensitive with a limit of detection (LOD) as low as 0.11 μg/mL. The type of mechanism by which quenching took place was also investigated by different means and was found to be static with a complementary inner filter effect. For quality purposes, the assessment of the validation criteria adhered to the ICHQ2(R1) recommendations. Finally, the proposed method was applied to a pharmaceutical dosage form of the drug (Vizimpro<sup>®</sup> Tablets) and the obtained results were satisfactory. Considering the eco-friendly aspect of the suggested methodology, using natural materials to synthesize N-CQDs and water as a diluting solvent added to its greenness profile.
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DOI: 10.3390/molecules28052351
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