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http://dx.doi.org/10.5806/AST.2012.25.2.152

Development and validation of a HPLC method for the simultaneous determination of chlorquinaldol and promestriene in complex prescription  

Lee, Seul-Ji (College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University)
Shin, Sang-Yeon (College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University)
Shin, Hae-Jin (College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University)
Lee, Jin-Gyun (College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University)
Kim, Dong-Hwan (Pharmaceutical Standardization Research and Testing Division, Korea Food & Drug Administration)
Lee, Su-Jung (Pharmaceutical Standardization Research and Testing Division, Korea Food & Drug Administration)
Han, Sang-Beom (Dept. of Pharmaceutical Analysis, College of Pharmacy, Chung-Ang University)
Park, Jeong-Hill (College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University)
Lee, Jeong-Mi (School of Pharmacy, Sungkyunkwan University)
Kwon, Sung-Won (College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University)
Publication Information
Analytical Science and Technology / v.25, no.2, 2012 , pp. 152-157 More about this Journal
Abstract
Currently, many types of compound preparations are being used but the quality control guidelines for their use are lacking. In case of single compound drug, the quality control methods are specified in the pharmacopeia. However, there is no method to simultaneously analyze compound preparations. In this study, a simple validated analytical method for HPLC separation of chlorquinaldol and promestriene is introduced. Validation was divided into categories including linearity, precision, accuracy (recovery) and system suitability. The contents of the products which are on the market were monitored using the validated analytical method and the robustness of the analytical method was tested by conducting an inter-laboratory validation.
Keywords
Quality control guidelines; Validation; High performance liquid chromatography (HPLC); Chlorquinaldol; Promestriene;
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