고시 수재 의약품 중 피라세탐 정 및 브롬화수소산페노테롤 정의 용출 시험법 개발

• 영문명: Development of Dissolution testing method for Piracetam Tablets and Fenoterol Hydrobromide Tablets in Korean pharmaceutical codex
• 발행기관: 대한약학회
• 저자명: 김은정(Eun-Jung Kim) 이진하(JinHa Lee) 박찬호(ChanHo Park) 손경희(KyungHee Sohn) 김인규(InKyu Kim) 김동섭(Dong-Sup Kim) 사홍기(HongKee Sah) 최후균(Hoo-Kyun Choi)
• 간행물 정보: 『약학회지』제55권 제4호 (2011년), 1~18쪽, 전체 18쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2011.08.30

영문 초록

Although the dissolution test can serve as an effective tool for quality control and predictor of in vivo performance, there are a number of drugs with no established dissolution specifications in Korean Pharmaceutical Codex (KPC). Among those commercially available, Piracetam Tablets and Fenoterol hydrobromide Tablets were selected to develop the dissolution testing method. The dissolution condition was determined based on the "Guidelines on Specifications of Dissolution tests for Oral dosage forms" of Korea Food & Drug Administration (KFDA). The dissolution test for Piracetam Tablets was carried out under sink condition with distilled water as dissolution medium, paddle rotation speed at 50 rpm and medium volume of 900 mL. More than 80 % of its label claim was released within 30 min. In case of Fenoterol hydrobromide Tablets, distilled water was also found to be suitable to ensure sink condition. The rotation speed of 50 rpm and 900 mL of dissolution medium were used to evaluate the dissolution profile. The dissolution rate of fenoterol hydrobromide was over 90% in 15min. The HPLC analysis methods were validated in terms of accuracy, precision, specificity, linearity, quantitation limit and range. The results suggested that the analytical methods used are simple and suitable to measure the dissolution rate of piracetam and fenoterol hydrobromide. Therefore, the analysis methods could be utilized in setting dissolution specifications of Piracetam Tablets and Fenoterol hydrobromide Tablets in the revised version of KPC.

키워드

Dissolution test Piracetam tablets Fenoterol Hydrobromide tablets