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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/ml Keywords: Pitavastatin calcium, UV spectrophotometric, Method Development, Validation, Stability-indicating method, ICH. [Download Article] [Download Certifiate] |