1*Associate Professor, Haldia Institute of Pharmacy, Hatiberia, Haldia, West Bengal-721657. Email: pharma.chemistry12@gmail.com. ORCID: https://orcid.org/0000-0002-6194-0202
2,3Department of Pharmaceutical Chemistry, Haldia Institute of Pharmacy, West Bengal, 721657, India
The present study focused on the synthesis of Schiff base derivatives of caffeine and the development of UV-visible spectrophotometric methods for their quantitative estimation. The synthesized compounds were further evaluated through method validation in accordance with ICH Q2 (R1) guidelines to ensure reliability. Caffeine was reacted with phenyl hydrazine in ethanol containing acetic acid under reflux (1:1 molar ratio) to form Schiff base derivatives. The resulting product was isolated by cooling, filtered, and purified by recrystallization. A stock solution (100 mg/100 mL) was prepared, and working solutions were analyzed at 230 nm using UV spectrophotometry. The method was validated for parameters including accuracy, precision, and linearity, limit of detection (LOD), limit of quantification (LOQ), robustness, and ruggedness. The results demonstrated satisfactory accuracy, with percentage recoveries of 101.36%, 100.81%, and 98.51% at 80%, 100%, and 120% concentration levels, respectively. Precision studies showed excellent repeatability with %RSD values below 0.3%. Linearity was observed over the range of 1.5–7.5 µg/mL with a correlation coefficient (r²) of 0.9998. LOD and LOQ were calculated as 3.17µg/mL and 9.6 µg/mL, respectively. Robustness and ruggedness studies (RSD < 0.3%) confirmed the consistency and reproducibility of the developed method.
Keywords: Caffeine, Schiff base, UV-visible spectrophotometry, ICH Q2(R1) validation, Analytical method development.
How to cite this article: Maity S, Suman P, Kantal KL. A Novel Derivatization UV Spectrophotometric Method Development And Validation For The Determination Of Caffeine By Condensation Method (Formation Of Schiff Base). Int J Drug Deliv Technol. 2026;16(3): 109-120. DOI: 10.25258/ijddt.16.3.15
Source of support: Nil.
Conflict of interest: None