Objective: Green pharmaceutical and bioanalytical methods for Voriconazole and Tadalafil
were developed and validated using an environment friendly organic modifier without any extraction
step. Replacing toxic solvent in bioanalytical HPLC is the first greening approach in chromatographic
drug analysis in plasma.
Method: Analytical C18 columns and mobile phases containing conventional solvents or propylene
carbonate with/without ethanol and/or buffer were used in optimization study.
Results: Optimized chromatographic conditions were Shim-Pack XR-ODS (100 × 2.0 mm, 2.2 µm)
column and the mobile phase consisted of propylene carbonate/(70% phosphate buffer (50 mM,
pH=3.0) + 30% ethanol) (10:90, v/v). Limit of detection and limit of quantification in tablet analysis
were respectively 0.1 µg mL-1 and 0.5 µg mL-1 for both Voriconazole and Tadalafil. Lower limit of
quantification in plasma analysis was found to be 0.005 µg mL-1 for both analyte.
Conclusion: Green HPLC methods presented here were accurate, precise, specific, sensitive, rugged,
robust, reliable in long-term use and successfully applied to pharmaceutical and plasma analysis.