Method Development and Validation of Pitavastatin Calcium and its Degradation Behavior under varied Stress Conditions by UV Spectrophotometric methods
Keywords:
Pitavastatin calcium, UV spectroscopic method, acid, alkali, oxidative, thermal and UV degradation.Abstract
UV spectrophotometric methods for the determination of pitavastatin calcium in pure and
pharmaceutical dosage forms were developed and validated as per ICH guidelines. The standard pitavastatin calcium
solutions were scanned between the ranges of 200-400 nm. The maximum absorbance of pitavastatin calcium in DMF
(method A), HCl (method B) and NaOH (method C) was recorded at 266 nm. They obeyed Beers law concentration in
the range of 10-45 μg/ml (method A), 0.25-2.0 μg/ml (method B) and 0.25-2.0 μg/ml (method C) with correlation
coefficients 0.9996, 0.9998 and 0.9998 respectively. Stability study showed high stability of pitavastatin calcium in
acidic, alkaline medium and at high temperature, but undergone degradation in oxidative stress condition. The
developed methods were validated for linearity, precision, accuracy, LOD, LOQ, ruggedness, robustness and recovery
studies. The proposed methods can be successfully used for the routine quality control analysis of pitavastatin calcium
in bulk and commercial pharmaceutical formulations.
