Фармацевтика Аналитика Акта

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HPLC Determination of Pitavastatin Calcium in Pharmaceutical Dosage Forms

Nanjappan Satheesh Kumar, Narayanan Nisha, Jayabalan Nirmal, Narayanan Sonali and J Bagyalakshmi

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 calcium using paracetamol as internal standard. The chromatographic system consisted of Shimadzu LC-10ATVP Pump, SPD-M10 AVP with PDA detector. Separation was achieved on the phenomenex C 18 (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. 0.5% Acetic acid: Acetonitrile 35:65 (%, v/v), was used as mobile phase with flow rate of 1 ml/min. UV detection was performed at 245 nm. A calibration graph was plotted which showed a linearity range between 1-5 μg/ml with the correlation coefficient of 0.9986. The LOD was 5 ng/ ml, while the LOQ was 20 ng/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 calcium.