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

The Korean Pharmaceutical Codex (KPC) analytical method of ambroxol hydrochloride and clenbuterol hydro- chloride formulation is complicated and needed to carry out multiple processes during the test.1) To improve the low effi-ciency 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 hydro-chloride 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 μg/ml for ambroxol, 0.021 μg/ml for clenbuterol syrup and 0.073 μg/ml for clenbuterol tablets.2) 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 man-ufactured products. This analytical method will be used for revising the monograph of ambroxol hydrochloride and clen-buterol hydrochloride formulation in next supplement of KPC.