Development and Validation of Sustainable RP-HPLC Method for Tofacitinib Quantification in MCM-41 and MCM-48 Silica...

Area of Science:

• Analytical Chemistry
• Materials Science
• Pharmaceutical Sciences

Background:

• Tofacitinib is a Janus kinase inhibitor used for autoimmune disorders.
• Mesoporous silica nanoparticles (MSNs) like MCM-41 and MCM-48 are investigated for drug delivery.
• Developing sustainable analytical methods is crucial for pharmaceutical research.

Purpose of the Study:

• To develop and validate a simple, rugged, and environmentally sustainable RP-HPLC method for Tofacitinib quantification.
• To apply the method for analytical studies of Tofacitinib-loaded MCM-41 and MCM-48 nanoparticles.
• To evaluate the environmental and analytical sustainability of the developed method.

Main Methods:

• RP-HPLC separation on a C18 column with an isocratic mobile phase (Milli-Q water/Acetonitrile).
• Photodiode array (PDA) detection at 287 nm with a 15-minute run time.
• Sustainability assessment using AGREE and RGB-12 whiteness models.

Main Results:

• The method demonstrated excellent linearity (r² = 0.9987), accuracy (98-102%), precision (0.06-1.31% RSD), and sensitivity (LOD: 0.28 µg/mL, LOQ: 0.848 µg/mL).
• High ruggedness (0.012-1.33% RSD) and specificity without excipient interference were observed.
• High AGREE (0.79) and RGB-12 (87.0) values confirmed enhanced sustainability and practical feasibility.

Conclusions:

• The developed RP-HPLC method offers reliable analytical performance aligned with green and white chemistry principles.
• The method is suitable for routine quality control and formulation research of Tofacitinib in MSN-based drug delivery systems.
• This novel sustainable method reduces analysis time and resource consumption compared to existing techniques.