Abstract
A new, rapid and sensitive high performance liquid chromatography (HPLC) assay was developed and validated, which utilized a monolithic column (100 × 4.6 mm I.D.) for the determination of lamivudine in pharmaceutical preparations. The method used a mobile phase consisting of acetonitrile/water (65:35, v/v) and flow rate of 2.0 mL/min. The elution of the analyte was monitored at 285 nm and conducted at ambient temperature. The method was validated with respect to linearity range, limit of detection and quantitation, precision, accuracy, selectivity, and robustness. The method exhibited low limit of detection (LOD) of 12.5 ng/mL, wide linearity range of 25-800 ng/mL and correlation coefficient (R
2
) greater than 0.999. Parameters of validation prove the precision of the method and its applicability for the determination of lamivudine in pharmaceutical tablet formulations. The method is fast (less than one minute) and is suitable for high throughput analysis of the drug.