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

복방제제 내 클로르퀴날돌과 프로메스트리엔에 대한 HPLC 기반 동시분석법의 개발 및 밸리데이션

  • Received : 2012.01.10
  • Accepted : 2012.02.17
  • Published : 2012.04.25

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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