Kinetic Determinations of Pitavastatin Calcium by Stability Indicating HPTLC Method

A simple, sensitive, precise, and stability-indicating high-performance thin-layer chromatographic method has been developed and validated for the quantitative determination of pitavastatin calcium (PTV) in a pharmaceutical dosage form in the presence of its degradation products. The stability of PTV was investigated under different stress conditions, including hydrolytic, oxidative, photolytic, and thermal, as recommended by the International Conference on Harmonization guidelines. PTV was separated on aluminum-backed silica gel 60 F254 high-performance thin-layer chromatography (HPTLC) plates as a stationary phase with ethyl acetate–methanol–toluene–glacial acetic acid (4:1:5:0.1, v/v/v/v) as a mobile phase. Regression analysis data for the calibration plots were indicative of good linear relationships between responses and concentration over the range 25–150 ng per band. The method was validated for linearity, precision, accuracy, robustness, specificity, and sensitivity. The drug was subjected to stre...