A simple, fast, and reliable separation and quantitation method of simvastatin in pharmaceutical dosage form was achieved by high speed LC/MS with excellent linear response (r2 = 0.9998) in the range of 0.5-82 ng/mL (equivalent to 2.5-410 pg onto column).

The LOD for simvastatin was 0.258 ng/mL and LOQ was 0.859 ng/mL. The simvastatin recovery ranged from 101.6% to 101.8% in three days. These results indicated that this approach can be applied as a reliable separation and quantitation method in the quality control of bulk and commercial tablet manufacturing process of simvastatin.