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

被引：0
作者：
Lee, Seul Ji [1 ,2 ]
Shin, Sang-yeon [1 ,2 ]
Shin, Hae-jin [1 ,2 ]
Lee, Jin Gyun [1 ,2 ]
Kim, Dong-Hwan [3 ]
Lee, Sujung [3 ]
Han, Sang Beom [4 ]
Park, Jeong Hill [1 ,2 ]
Lee, Jeongmi [5 ]
Kwon, Sung Won [1 ,2 ]
机构：
[1] Seoul Natl Univ, Coll Pharm, Seoul 151742, South Korea
[2] Seoul Natl Univ, Pharmaceut Sci Res Inst, Seoul 151742, South Korea
[3] Korea Food & Drug Adm, Pharmaceut Standardizat Res & Testing Div, Chungbuk 363951, South Korea
[4] Chung Ang Univ, Coll Pharm, Dept Pharmaceut Anal, Seoul 156756, South Korea
[5] Sungkyunkwan Univ, Sch Pharm, Suwon 440746, South Korea
来源：
ANALYTICAL SCIENCE AND TECHNOLOGY | 2012年 / 25卷 / 02期
关键词：
Quality control guidelines; Validation; High performance liquid chromatography (HPLC); Chlorquinaldol; Promestriene;
D O I：
10.5806/AST.2012.25.2.152
中图分类号：
O65 [分析化学];
学科分类号：
070302 ; 081704 ;
摘要：
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.
引用
收藏
页码：152 / 157
页数：6
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