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

Panchal H. J, Suhagia B. N

Acta Chromatographica

2011

Vol. 23, no. 1

81--94

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.

Simultaneous analysis of atorvastatin calcium and losartan potassium in tablet dosage forms by RP-HPLC and HPTLC

Panchal H. J, Suhagia B. N

Acta Chromatographica

2010

Vol. 22, no. 2

173--187

Two simple and accurate reversed-phase high-performance liquid chromatography (HPLC) and high-performance thin-layer chromatography (HPTLC) methods for simultaneous determination of atorvastatin calcium and losartan potassium in tablet dosage forms have been established and validated. The HPLC separation was achieved on a Phenomenex Luna C 18 column (250 mm, 4.6 mm i.d., 5 μm) with 0.05 M potassium dihydrogen phosphate buffer (pH 5.4)-acetonitrile 45:55 (%, v / v ) as isocratic mobile phase at a flow rate of 1 mL min -1. The retention times were approximately 7.56 and 3.73 min for atorvastatin calcium and losartan potassium, respectively. Quantification was achieved at 238 nm with a photodiode-array (PDA) detector over the concentration range 0.5–5 μg mL -1, for each compound, with mean recoveries of 100.67 ± 0.58 and 100.51 ± 0.63% for atorvastatin calcium and losartan potassium, respectively. The HPTLC separation was achieved on silica gel 60 F254 HPTLC plates with methanol-carbon tetrachloride-ethyl acetate-glacial acetic acid 8:63.6:28:0.4 ( v / v ) as mobile phase. The retardation factors ( R F ) were approximately 0.45 and 0.30 for atorvastatin calcium and losartan potassium, respectively. Quantification was achieved by ultraviolet (UV) detection at 238 nm over the concentration range of 50–500 ng band -1 for each, with mean recoveries of 100.59 ± 0.47 and 100.48 ± 0.81% for atorvastatin calcium and losartan potassium, respectively. Both methods were validated, and the results were compared statistically by use of a paired t -test. The methods were found to be simple, specific, accurate, precise, and robust, and were successfully used for analysis of the drugs in tablet dosage forms without interference from common excipients.