Development of Simple Spectrophotometric method to Determinate Pitavastatin Calcium in Bulk and Pharmaceutical Preparations

An accurate, precise, sensitive and direct extraction-free simple spectrophotometric method has been developed and applied to determine Pitavastatin calcium (PTV) in raw material and tablets preparations. This Spectrophotometric method is based on the formation of yellow colored ion-pair complex in chloroform by Bromocresol Green (BCG). The complex has maximum absorptivity at 416 nm. The variable factors affecting the reaction such as solvents, time, and temperature and reagent concentration were studied and optimized to achieve the best results. Beer's law is obeyed over concentration ranges (2 - 24) pg/mL. Regression analysis showed a good correlation coefficient R2 = 0.9994. The limit of detection (LOD) and limit of quantification (LOQ) were to be 0.19pg/mL and 0.59pg/mL respectively and the molar absorptivity coefficient 61706 L/mole/cm. The average percent recovery was calculated and it was in range 98.59-101.97% for Pitavastatin calcium. All studied samples showed that the drug levels were confirmed due to Japanese pharmacopeia legislation.