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KMID : 0614020090240010088
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Journal of Pharmaceutical Sciences (C.N.U.)
2009 Volume.24 No. 1 p.88 ~ p.92
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pH-Solubility Determination of Atorvastatin by Improved HPLC Method
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Jin Shun-Ji
Kim Min-Soo
Kim Jeong-Soo
Seo Soek-Jun
Lee Gye-Won
Lee Si-Beum
Hwang Sung-Joo
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Abstract
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An improved high performance liquid chromatographic (HPLC) method was developed to detect atorvastatin. Liquid chromatography was performed on a Waters XTerra™ RP C_(18) (5 ㎛m, 4.6×250 mm) column and mobile phase consisted of acetonitrile-acetate buffer (pH 4.0)-methanol 48:42:10 (v／v／v) with the flow rate of 0.9 ml／min. The effluent was monitored by a UV detector at the wavelength of 245nm. The corresponding calibration curve was a good linearity over the range of 0.5∼100.0 ㎍／ml. The limit of detection and the limit of quantitation were 10.0 ng／ml and 29.0 ng／ml, respectively. Under the above conditions, the effects of pH to the solubility of atorvastatin calcium were investigated in the range of 2.0∼7.9 for pH at 30℃. Results showed that pH influenced on the solubility extremely. It was observed that the solubility increased as the pH increased (especially at pH > 4.0). The apparent solubility of atorvastatin calcium increased about 20 times, from 10.95 ㎍／ml (pH 2.0) to 201.49 ㎍／ml (pH 7.9).
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KEYWORD
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atorvastatin, HPLC, UV detector, pH-solubility
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