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KMID : 0385520100230060587
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Analytical Science & Technology
2010 Volume.23 No. 6 p.587 ~ p.594
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Analytical method validation of oxiracetam using HPLC
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Kim Yoo-Gon
Seo Houng-Seok
Won Chan-Hee
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Abstract
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This study aims to determine that the test of medicines containing oxiracetam as their main ingredient was properly performed according to protocol. Furthermore, the study is to provide the written form of protocol in order to examine the validity of the HPLC analytical method for the quantitative analysis of oxiracetam in the finished products. In this experiment, system suitability, precision, linearity, range, accuracy, specificity, quantitative limit, and detection limit of the analytical method which was used to determine the contained quality of oxiracetam, were examined. The result shows that system suitability indicates 0.127% RSD, plate number 15081, tailing factor 0.49, and resolution 32.41. The experiment of precision reveals the result of below 0.359% for repetitiveness and among the subjects. In the linearity experiment, a coefficient of correlation (R²) indicates that it is 1. The accuracy experiment satisfies the standards of the recovery test, which is minimum 98.4% and maximum 99.6%. Detection limit is 0.1 ㎎/L and quantitative limit was found to be 0.5 ㎎/L. The experiment to check the specificity also satisfies the standards, so the finished product using oxiracetam as the main ingredient is verified as suitable.
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KEYWORD
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analytical method validation, HPLC, oxiracetam, system suitability
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