Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING UV SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF PITAVASTATIN CALCIUM

Konica Vijay Aglawe*, Umesh Pralhad Kharat, Chaitali C. Dongaonkar, Vijayalaxmi A. Chavan

ABSTRACT

The UV –Visible spectrophotometric method was developed for quantitative analysis of Pitavastatin calcium. The calibration curve of Pitavastatin calcium in ethanol was found linear (r2 = 0.999) between the concentration range 2-10 μg/ml. Accuracy of the method was determined by percent recovery and found to be 99.37 ± 0.1410674% recovery for pure drug. Pitavastatin calcium containing tablets (PIVASTA 2 mg) were used for percent recovery studies and the method has shown 99.19 ± 0.2900575% recovery. The developed method was precise as the %RSD values of precision studies were less than 2. Intra-day and inter-day precision were found as 1.419367% and 1.36342% respectively. The LOQ and LOD were found as 0.99 μg/mland 0.32 μg/ml. The method also found rugged and robust. The degradation studies has carried out in various conditions like acidic, alkaline, neutral, photolytic, thermal, oxidation condition and uv light degradations. It was found that Pitavastatin calcium was stable in neutral hydrolysis and UV light degradation. Hence, the developed method was found to be simple, sensitive, specific, accurate and precise for analysis of Pitavastatin calcium.

Keywords: Pitavastatin calcium, UV spectrophotometric, Method Development, Validation, Stability-indicating method, ICH.