IMPLEMENTATION OF VALID UV-SPECTROPHOTOMETRIC METHOD FOR QUANTIFICATION OF DACOMITINIB IN PURE FORM AND NANO-DRUG DELIVERY SYSTEMS: A GREENNESS ASSESSMENT USING ESTABLISHED METRICES.

Document Type : Original Article

Authors

1 Pharmaceutics and Industrial Pharmacy Department, Faculty of Pharmacy, Helwan University, Ain Helwan, Cairo 11795, Egypt

2 Department of Pharmaceutics, Faculty of Pharmacy, Delta University for Science and Technology, Gamasa 11152, Egypt

Abstract

Dacomitinib (DMB), is a chemotherapeutic drug recently approved by FDA rendering it as fresh candidate that is expected to be heavily subjected to research in the near future especially in the nanotechnology field. The study aimed to develop a valid economic process for quantifying DMB in both pure and pharmaceutical dosage forms using UV-visible spectroscopy method. Cubosomes are interesting nanocarriers that have shown a great role in successful delivery of chemotherapeutic drugs to different tumor sites, so they were selected for DMB encapsulation to increase our challenge. Measurement of wavelength maximum for DMB in different solvents was conducted followed by construction of absorbance curves to detect regression values. For further justification our developed method was statistically compared to one of the rare methods found for determination of DMB which was HPLC determination for the drug in its pure form or encapsulated in cubosomes. Validation was accomplished conferring to the international conference on harmonization (ICH) guidelines. The produced data indicated that the developed approach was an economic analysis method, precise and complies with the recommendations of ICH guidelines that could be used in the future determination of drug as evidenced by the fact that the RSD was less than 2% , good linearity was achieved in the range of 2-14 ug/mL and the LOD and LOQ was 0.47 and 1.4 μg/mL respectively. The greenness of the method was assessed using GAPI and AGREE metrices, indicating its potential for environmentally sustainable application.

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