CAJ | 학술논문

目的：建立高效液相色谱法测定复方妥英麻黄茶碱胶囊中苯妥英钠的含量。方法采用Dia-monsil钻石C18（150 mm×4．6 mm，5μm）色谱柱，以甲醇-水（50∶50）为流动相，检测波长为215 nm，流速为1．0 ml/min，柱温设置为室温。结果3批复方妥英麻黄茶碱胶囊及片剂的标示量为97．88％（20121202）、99．56％（20121203）、96．41％（20121204），102．9％（片剂）。结论本方法简便，结果准确可靠，可用于该制剂质量控制的有效方法。
목적：건립고효액상색보법측정복방타영마황다감효낭중분타영납적함량。방법채용Dia-monsil찬석C18（150 mm×4．6 mm，5μm）색보주，이갑순-수（50∶50）위류동상，검측파장위215 nm，류속위1．0 ml/min，주온설치위실온。결과3비복방타영마황다감효낭급편제적표시량위97．88％（20121202）、99．56％（20121203）、96．41％（20121204），102．9％（편제）。결론본방법간편，결과준학가고，가용우해제제질량공제적유효방법。
Objective To establish the determination of the content of phenytoin in Compound Theophylline and Ephedrine Capsules by high performance liquid chromatography (HPLC). Methods A chromatographic column of Diamonsil C18 (150 mm ×4.6 mm, 5 μm) was used. The mobile phase was consisted of a mixture of methanol and water (50∶50). The wave length was 215 nm, the flow rate was 1.0 ml/min, and the column temperature was set to room temperature. Results The percentage amount of phenytoin in three batches of Compound Theophylline and Ephedrine Capsules and Compound Theophylline and Ephedrine Tablets were 97.88% (20121202), 99.56%(20121203), 96.41% (20121204) and 102.9%, respectively. Conclusions The method established in this study is simple with accurate and reliable results, and may be useful in quality control for the capsules.