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KMID : 0370220130570030205
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Yakhak Hoeji
2013 Volume.57 No. 3 p.205 ~ p.212
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Development of Dissolution Test for Itopride Hydrochloride Tablets and Tiropramide Hydrochloride Tablets)
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Kim Jung-Hyun
Lee Jong-Hwa
Choi Lan
Choi Yeon-Hee
Lee Jong-Chul
An Ji-Hye
Lee Kwang-Moon
Shim Young-Hoon
Kang Shin-Jung
Sah Hong-Kee
Choi Hoo-Kyun
Kim In-Kyu
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Abstract
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Dissolution test has been performed to control drug quality and to predict in vivo drug release profile of solid dosage forms, so there’s a drift towards setting dissolution test instead of disintegration test. However, some solid dosage forms in Korea Pharmaceutical Codex (KPC) are not established the dissolution test yet, so these monographs are necessary to set the specification of dissolution test. In this study, we developed the specification and test method of dissolution test for itopride hydrochloride tablets and tiropramide hydrochloride tablets which are not established the dissolution test yet. According to the "Manual for Guideline Application for Validation of Analytical Procedures" and "Guidelines on Specification of Dissolution test for Oral dosage form" of Korean Pharmacopoeia (KP), we validated and established each development method. Based on the preliminary dissolution profile, we set the dissolution condition(paddle apparatus, pH 1.2 media, 50 rpm). For this condition, we performed the main dissolution test to determine the specification (45 min, 85%). Finally, we validated each analytical method by specificity, linearity, accuracy and precision. These developed methods will be included the next supplement of KPC and also contributed to the quality control of medicines.
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KEYWORD
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dissolution test, itopride hydrochloride, tiropramide hydrochloride
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