Abstract
A quantitative high-performance thin-layer chromatographic method for determination of pitavastatin calcium in pharmaceutical preparations has been established and validated. Pitavastatin calcium from the formulations was separated and identified on silica gel 60F 254 HPTLC plates with toluene-methanol-glacial acetic acid 7.6:2.36:0.04 ( v/v ) as mobile phase. The plates were developed to a distance of 8 cm and well resolved bands were obtained for pitavastatin calcium. Quantification was performed at 238 nm. The method was validated for specificity, precision, robustness, and accuracy. The calibration plot for pitavastatin calcium standard was linear in the range 40–250 ng per band with r = 0.9992, slope = 8.2415, and intercept = 203.2359. The limits of detection and quantification were 6.6 and 20.0 ng per band, respectively. The method is selective, sensitive, and specific with potential application in pharmaceutical analysis.
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