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 F 254 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 stress degradation and peaks of all the degradation products were well resolved from that of the pure drug, with significantly different R f value, which indicates the specificity and stability-indicating properties of the method. The kinetic determination was evaluated in acid conditions. The acid degradation of PTV showed an apparent first-order kinetics and rate constants were found to be 0.00202 mg=mL=min in 0.1 N HCl at 75 C.
A sensitive, specific and stability-indicating reversed phase high performance liquid chromatography-diode array detection method was developed for the quantitative determination of fluvastatin sodium in the presence of its degradation products. The chromatographic separation was performed on a Phenomenex Luna C18 column (150 X 4.0 mm, 5µm) in isocratic mode using acetonitrile and 0.02M potassium phosphate buffer (50 + 50, v/v, pH 5.0 adjusted with potassium hydroxide) as the mobile phase at a flow rate of 1.0 ml/min. The quantification was performed with a photodiode array detector at 235nm based on peak area. The method showed good linearity over the concentration range of 5-40 µg/mL with a detection limit of 1.1µg/mL and quantification limit of 3.3µg/mL. The proposed LC method was used to investigate the kinetics of acidic and oxidative degradation of fluvastatin sodium. The acidic and oxidative degradation had shown an apparent first-order kinetics and rate constants were found to be 0.0191µg/mL/min and 0.0048µg/mL/min, respectively.
An isocratic stability-indicating reverse phase high performance liquid chromatographic diode array detection method has been developed and validated for the quantitative determination of pitavastatin calcium in the presence of its degradation products. The chromatographic separation was achieved on Phenomenex Luna C18 column (250 X 4.0 mm id, 5μm) in the isocratic mode using acetonitrilemethanol- water (35:25:40, v/v/v, pH 3 adjusted with orthophosphoric acid) as mobile phase. The drug is subjected to different accelerated stress conditions and peaks of the degradation products were well resolved from the pure drug, which indicates the specificity and stability-indicating properties of the method. The method was linear (r= 0.9998) over the concentration range of 5-30 μg/mL. The proposed method was used to investigate the degradation kinetics of PTV in acidic condition at different temperatures. Degradation of pitavastatin followed first-order kinetics, and rate constant (k), half life (t1/2), time left for 90% potency (t90) and energy of activation were calculated.
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