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KMID : 0385520120250020152
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Analytical Science & Technology
2012 Volume.25 No. 2 p.152 ~ p.157
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Development and validation of a HPLC method for the simultaneous determination of chlorquinaldol and promestriene in complex prescription
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Lee Seul-Ji
Shin Sang-yeon
Shin Hae-jin
Lee Jin-Gyun
Park Jeong-Hill
Kwon Sung-Won
Kim Dong-Hwan
Lee Su-Jung
Han Sang-Beom
Lee Jeong-Min
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Abstract
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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.
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KEYWORD
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Quality control guidelines, Validation, High performance liquid chromatography (HPLC), Chlorquinaldol, Promestriene,
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