Volume : 13, Issue : 07, July – 2026

Title:

METHOD DEVELOPMENT, VALIDATION AND ESTIMATION OF SINGLE SYNTHETIC DRUG TUCATINIB BY RP-HPLC GREEN ANALYSIS IN API FORM AND PHARMACEUTICAL DOSAGE FORM

Authors :

Husna Kanwal Qureshi*, S.H. Rizwan, Syed Almas Ahmed, Mohammed Arfath, Seham Sultana, Urooj Ahed, Saba Tarannum, Farha Yasmeen

Abstract :

An analytical, simple, accurate, robust, specific, rapid, and precise reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the estimation of Tucatinib in bulk and pharmaceutical dosage forms. Chromatographic separation was achieved on a Hypersil ODS C18 column (2.1 mm × 100 mm, 5 µm) using an optimized eco-friendly mobile phase consisting of ethanol and water (65:35% v/v) at a flow rate of 0.7 mL/min, with detection carried out at 260 nm. The retention time of Tucatinib was found to be 2.3 ± 0.02 min, indicating rapid analysis with reduced solvent consumption. The method exhibited excellent linearity over the concentration range of 24–120 µg/mL with a correlation coefficient (r) of 0.998. The precision of the method was confirmed with %RSD values less than 2.0%. The method was validated in accordance with ICH guidelines for accuracy, precision, linearity, robustness, ruggedness, limit of detection (LOD), and limit of quantitation (LOQ). The percentage recovery was found within the acceptable range of 98–102%, confirming the accuracy of the method. The developed method was successfully applied for the quantitative estimation of Tucatinib in pharmaceutical tablet formulations, yielding assay results of 99.7%. In addition to analytical validation, the method was evaluated for its environmental sustainability using green analytical chemistry assessment tools. The Analytical Eco-scale score was found to be 91, indicating excellent greenness. The AGREE score of 0.82 demonstrated high compliance with the principles of green analytical chemistry, while the GAPI assessment revealed predominantly green zones with minimal environmental impact. The replacement of conventional toxic solvents such as acetonitrile with ethanol significantly enhanced the eco-friendly profile of the method. In conclusion, the developed RP-HPLC method is not only reliable and efficient but also environmentally sustainable, making it highly suitable for routine quality control analysis in pharmaceutical industries.
Key Words: Tucatinib, RP-HPLC, Method Development, Validation, Green Analytical Chemistry, AGREE, GAPI, Eco-scale.

Cite This Article:

Please cite this article in press Husna Kanwal Qureshi et al., Method Development, Validation And Estimation Of Single Synthetic Drug Tucatinib By Rp-Hplc Green Analysis In Api Form And Pharmaceutical Dosage Form, Indo Am. J. P. Sci, 2026; 13(07).

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