Abstract

A novel, accurate and precise RP-UFLC method for determination of xanthinol nicotinate has been developed and validated. Separation was achieved on an Enable C₁₈G column (250 mm × 4.6 mm i.d., 5 µm) using acetonitrile: 10 mM TBAHS (40:60, v/v) as mobile phase at a flow rate of 0.8 mL/min and PDA detection at 274 nm. Linearity was observed in the concentration range of 1.0-60 µg/mL (r²=0.999). The method was validated for accuracy, precision, stability, specificity, robustness and system suitability. Forced degradation was performed by using HCl, NaOH, H₂O₂, thermal and UV radiation. The method was used successfully for the determination of xanthinol nicotinate in tablet dosage form.

Keywords

Xanthinol, RP-UFLC, Validation, Stability, Nicotinic acid