New cost effective RP-HPLC method development and evaluation for quantitative estimation of Pitavastatin in pharmaceutical formulation

A simple, sensitive, reliable and rapid reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for the determination of pitavastatin in bulk and pharmaceutical dosage form. The chromatographic system consisted of waters (784), 515 binary Pump, data Ace with UV-Visible detector. Separation was achieved on the thermo C18 (250 x 4.60), 5 μ particle size column in isocratic mode at room temperature. The sample was introduced through an injector valve with a 20 μl, sample loop. 20mM KH2PO4 (pH-3.0 with OPA): Acetonitrile 20:80 (%, v/v), was used as mobile phase with flow rate of 1 ml/min. UV detection was performed at 250 nm. A calibration graph was plotted which showed a linearity range between5-25 μg/ml with the correlation coefficient of 0.997. The LOD was 0.095μg/ ml, while the LOQ was 0.271 μg/ml. Validation studies revealed the method is specific, rapid, reliable and reproducible. To study the validity of the method, recovery studies and repeatability studies were carried out using the same optimum conditions. The system suitability studies were also calculated which includes column efficiency, resolution, capacity factor and peak asymmetrical factor. Therefore the proposed method is reliable, rapid, precise and selective so may be used for the quantitative analysis of pitavastatin.