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KMID : 0614020060210010019
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Journal of Pharmaceutical Sciences (C.N.U.)
2006 Volume.21 No. 1 p.19 ~ p.24
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Enantioseparation and Quality Evaluation of Naproxen by High Performance Liquid Chromatography
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Jeong Su-Jin
Kang Jong-Seong
Chen Quan-Cheng
Lee Eun-Joo
Lee Eun-Sil
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Abstract
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Enantiomeric separation of naproxen is necessary in drug evaluation processes as the pharmacological activity of naproxen resides mainly in the (S)-enantiomer, The enantioseparation of naproxen was carried out with three different stationary phases. The methods were validated with the terms of linearity, intraday and interday precision, accuracy, selectivity and recovery. Among the selected stationary phases, ChiroSil DMB column with hexane : t-butylmethylether : acetic acid (60:40:0.1, v/v/v) as mobile phase showed the best enantioseparation of the naproxen in the commercial preparations. The wavelength for detection was 270 nm and flow rate was 2.0 mL/min. The contents of (S)-naproxen in the commercial preparations were 92.7 - 98.3%, indicating that all tested preparations were satisfactory to current regulation. However, the contents of (R)-naproxen as impurity in the commercial preparations were varied from 0.08% to 1.08%.
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KEYWORD
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Naproxen, enantioseparation, impurity, validation, HPLC
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