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고시수재 의약품 중 암브록솔염산염 및 클렌부테롤염산염 함유 제제의 함량 시험법 개선
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  • 고시수재 의약품 중 암브록솔염산염 및 클렌부테롤염산염 함유 제제의 함량 시험법 개선
  • Development of Analytical Method for Ambroxol Hydrochloride and Clenbuterol Hydrochloride Formulation in Korean Pharmaceutical Codex
저자명
이태웅,정래석,박수진,최란,심영훈,최보경,곽효선,Lee. Tae-Woong,Jeong. Rae-Seok,Park. Soo-Jin,Choi. Lan,Shim. Young-Hun,Choi. Bo-Kyung,Kwak. Hyo-Sun
간행물명
약학회지
권/호정보
2014년|58권 3호|pp.190-199 (10 pages)
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대한약학회
파일정보
정기간행물|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

The Korean Pharmaceutical Codex (KPC) analytical method of ambroxol hydrochloride and clenbuterol hydrochloride formulation is complicated and needed to carry out multiple processes during the test. To improve the low efficiency of analytical procedure that makes pharmaceutical laboratory consume much time and high cost to conduct the test of this formulation, this study was performed for simplifying the pretreatment process and optimizing conditions of the HPLC assay. The analytical procedure using HPLC was developed to establish analytical specification for ambroxol hydrochloride and clenbuterol hydrochloride formulations. The newly developed analytical method has good linearity ($R^2$ >0.999), specificity, precision (RSD<1.0%) and the recovery ranges of 98.50~101.84% for ambroxol, 98.29~101.35% for clenbuterol syrup and 98.66~101.71% for clenbuterol tablets. The LOQs were 0.204 ${mu}g/ml$ for ambroxol, 0.021 ${mu}g/ml$ for clenbuterol syrup and 0.073 ${mu}g/ml$ for clenbuterol tablets. The new method was performed with commercially available samples to confirm analytical conditions and validated to be suitable for saving time and cost to control the quality of routine manufactured products. This analytical method will be used for revising the monograph of ambroxol hydrochloride and clenbuterol hydrochloride formulation in next supplement of KPC.