Stability-indicating liquid chromatographic method for analysis of pitavastatin calcium in tablet dosage forms

摘要

A simple, specific, sensitive, precise, accurate, and robust stability-indicating reversed-phase liquid chromatographic (LC) method has been established for analysis of pitavastatin calcium in tablet dosage forms. LC separation was achieved on a 250 mm × 4.6 mm i.d., 5-μm particle, C18 column with acetonitrile-water-triethylamine 80:19.8:0.2 (υ/υ), adjusted to pH 3.5 ± 0.05 with orthophosphoric acid as isocratic mobile phase at a flow rate of 1.5 mL min~(-1). Detection, with a photodiode-array detector, was at 238 nm, the wavelength of maximum absorbance in a spectrum obtained from its solution in methanol. The retention time was approximately 5.70 min. The method was validated for linearity, accuracy, precision, limits of detection and quantification, and robustness. Quantification was performed over the concentration range 0.1-2.5 μg mL~(-1). Mean recovery was 100.26 ± 0.75%. The limit of detection (LOD) was 0.0055 μg mL~(-1). The method was successfully used for analysis of pitavastatin calcium in tablets and for stability studies, because the method separates pitavastatin calcium from its degradation products and from excipients.