Development and Validation of a UV-Vis Spectrophotometric Method for Determination of Pitavastatin in Bulk and Its Dosage Form
Author (s): Saroj Kanta Bisoyi, Sudhir Kumar Sahoo, Saroj Kumar Panda
Department of analysis, Royal college of pharmacy and health sciences Andhapasara
Road, Berhampur, Ganjam, Pin-760002, Odisha.
The present work aimed at developing Assay UV-Vis Spectrophotometric method for determination of Pitavastatin in Pitavastatin Tablets. It exhibited absorption maxima at 245 nm in methanol water (50:50). The method is specific there is no interference with the blank. The linearity within the range of 2.042 mcg/ml to 12.252mcg/ml with regression coefficient of 0.999. The % recovery within the range of 99.21 to 101.11 and the standard deviation and %relative standard deviations are less than 2. The method was found to be precise according to the method precision data, intermediate precision data and intraday precision data with the standard deviation and % relative standard deviation less than 2. The method was rugged and robust and % relative standard deviation less than 2. The proposed method was found suitable, rapid, cost effective, accurate, precise, robust and rugged for Assay routine analysis of Pitavastatin in its marketed dosage form.
Keywords: Pitavastatin, Assay, UV-Spectroscopy, Development, Validation, ICH.