Development and Validation of Sustainable RP-HPLC Method for Tofacitinib Quantification in MCM-41 and MCM-48 Silica
Vidhi S Pandya1, Nidhi R Trivedi1, Manish N Nandpal1
1Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology, CHARUSAT Campus, Changa - 388421, Anand, Gujarat, India.
Background:
Tofacitinib is a Janus kinase inhibitor approved by the FDA, for the treatment of autoimmune disorders.
Objective:
The research aimed to develop, validate, and apply a simple, rugged, and environmentally sustainable RP-HPLC method for the quantitative estimation of Tofacitinib in in-house developed Mesoporous Silica Nanoparticles (MCM-41 and MCM-48), intended for formulation-related analytical applications, while systematically evaluating environmental and analytical sustainability.
Method:
The chromatographic separation was achieved on Inertsil® C18 column using an isocratic mobile Phase of Milli-Q water and Acetonitrile (65:35, v/v) at a Flow rate of 1.0 mL/min, with PDA detection at 287 nm and a total run time of 15 min. The validated approach was applied to formulation based analytical studies. Environmental and analytical sustainability was evaluated using the AGREE and the RGB-12 whiteness model.
Results:
The method exhibited excellent specificity without interference from formulation excipients and showed Linearity over 1-24 µg/mL (r² = 0.9987). High accuracy (98-102%), precision 0.06-1.31% RSD), and sensitivity (LOD - 0.28 µg/mL and LOQ - 0.848 µg/mL) in compliance with ICH guidelines, enabled reliable estimation of Tofacitinib. The method demonstrated good ruggedness (0.012-1.33% RSD), indicating reliability under small deliberate changes. High AGREE and RGB-12 whiteness (0.79 and 87.0) values confirmed the enhanced sustainability and practical feasibility.
Conclusion:
The developed RP-HPLC method integrates reliable analytical performance with green and white chemistry principles, rendering it suitable for routine quality control and formulation-oriented research involving mesoporous silica based drug delivery systems.
Highlights:
A novel sustainable RP-HPLC method was developed and validated for the analysis of TFC-loaded MCM-41 and MCM-48 MSNs. The method demonstrated excellent performance in accordance with ICH Q2 (R2) guidelines. It was successfully applied for drug content determination and in vitro diffusion studies. Sustainability assessment using AGREE and RGB-12 models confirmed favourable greenness and whiteness, with reduced analysis time and resource consumption compared to reported methods.
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