Browse > Article

Development of Dissolution Test Method for Buflomedil Hydrochloride Tablets and Ticlopidine Hydrochloride Tablets  

Lee, Ryun-Kyung (Hazardous Substances Analysis Division, Daegu regional Korea Food & Drug Administration)
Jeong, Gyeong-Rok (Hazardous Substances Analysis Division, Daegu regional Korea Food & Drug Administration)
Oh, Hyun-Sook (Hazardous Substances Analysis Division, Daegu regional Korea Food & Drug Administration)
Shim, Jee-Youn (Hazardous Substances Analysis Division, Daegu regional Korea Food & Drug Administration)
Suh, Sang-Chul (Hazardous Substances Analysis Division, Daegu regional Korea Food & Drug Administration)
Lee, Hyo-Jung (Hazardous Substances Analysis Division, Daegu regional Korea Food & Drug Administration)
Kim, Min-A (Hazardous Substances Analysis Division, Daegu regional Korea Food & Drug Administration)
Park, Seong-Min (Hazardous Substances Analysis Division, Daegu regional Korea Food & Drug Administration)
Lee, Kyu-Ha (National Institute of Food and Drug Safety Evaluation, Osong Health Technology Administration Complex)
Sohn, Kyung-Hee (National Institute of Food and Drug Safety Evaluation, Osong Health Technology Administration Complex)
Kim, In-Kyu (National Institute of Food and Drug Safety Evaluation, Osong Health Technology Administration Complex)
Sah, Hong-Kee (College of Pharmacy, Ewha Womans University)
Choi, Hoo-Kyun (College of Pharmacy, Chosun University)
Cho, Tae-Yong (Hazardous Substances Analysis Division, Daegu regional Korea Food & Drug Administration)
Hong, Choong-Man (Hazardous Substances Analysis Division, Daegu regional Korea Food & Drug Administration)
Publication Information
YAKHAK HOEJI / v.56, no.4, 2012 , pp. 211-216 More about this Journal
Abstract
Drug dissolution test has been used for the purpose of both quality control of solid oral dosage forms and predicting in vivo drug release profiles. In this study, the dissolution profiles of buflomedil hydrochloride tablets and ticlopidine hydrochloride tablets were investigated according to the "Guidelines on Specifications of Dissolution tests for Oral dosage forms" of Korean Pharmacopoeia (KP). The analytical method using HPLC was validated. The validation was performed in terms of specificity, linearity, accuracy, precision and limit of quantitation.
Keywords
dissolution test; buflomedil - HCl; ticlopidine - HCl;
Citations & Related Records
연도 인용수 순위
  • Reference
1 대한약전 9개정 : 경구용의약품의 용출규격 설정 지침 (2007).
2 식품의약품안전청 고시 : 의약품동등성시험관리규정 (2005).
3 대한약전 9개정 : 의약품등 분석법의 밸리데이션에 대한 지침 (2007).
4 McTavish, D., Faulds, D. and Goa, K. L. : An updated review of its pharmacology and therapeutic use in platelet dependent disorders. Drugs 40, 238 (1990).
5 Handin, R. I. : Disorders of the platelet and wessel wall. In: Fauci, A. S., Braunwald, E., Isselbacher, K. J. Harrisons principle of internal medicine. 14th ed. New York, NY: McGraw-Hill Book Co 735 (1998).
6 Yu, K. H., Lee, B. C., Kwon, K. H., Song, H. K. and Kim, S. M. : The inhibitory effect of ticlopidine to platelets aggregation. J. Korean Neurol. Assoc. 12, 436 (1994).
7 Haas, W. K., Easton, J. D. and Adams, H. P. : A randomized trial comparing ticlopidine hydrochloride with aspirine for prevention of stroke in high-risk patients. N. Engl. J. Med. 321, 501 (1989).
8 Lanzon, L., Bergqvist, D., Boberg, J., Boberg, M., Eriksson, I., Lindgarde, F. and Persson, G. : Prevention of myocardial infarction and stroke in patients with intermittent claudication; effects of ticlopidine. Results from STIMS, the Swedish Ticlopidine Multicenter Study. J. Intern. Med. 227, 301 (1990).
9 Symeonidis, A., Kouraklis-Symeonidis, A., Seimeni, U., Galani, A., Giannakoulas, N., Fragopanagou, E., Tiniakou, M., Matsouka, P. and Zoumbos, N. : Ticlopidine-induced aplastic anemia: two new case reports, review, and meta-analysis of 55 additional case. Am. J. Hematol. 71, 24 (2002).
10 식품의약품안전청 : 대한약전외 의약품등 기준 제 3개정 (2007).