應用HPLC方法於Cephalexin膠囊製劑之品質管制

APPLICATION OF HPLC FOR QUALITY CONTROL OF CEPHALEXIN

一般藥廠Cephalexin膠囊製劑之品質管制例行工作包括鑑別、力價測定及溶離度試驗等項目，本實驗乃利用高效液相層析法來代替傳統的微生物分析法來進行上述之品管工作。所使用層析管為μBondapak C18，移動相為甲醇與1.25%冰醋酸（25:75） 之混合液，內部對照標準品為Acetaminophen，檢測波長為UV254 nm，於流速為1.0 mL/min 時，滯留時間約8.5分鐘，應用此方法針對市售六家廠牌之Cephalexin膠囊製劑做品質調查研究，包括含量均一度（ Content uniformity），溶離度試驗（Dissolution test）及回收率（Recovery）等試驗，結果顯示其滯留時間及回收率均不會受製劑中不同賦形劑之影響，此方法應用在Cephalexin膠囊製劑之品質管制上，具有簡單，迅速及特異性等優點。

A reversed phase high performance liquid chromatographic method was developed for the assay of cephalexin. The samples were analysed on a µ-Bondapak (C18) column with a mobile phase consisting of methanol and acetic acid. Our previous study has shown that this method is a suitable substitute for the microbiological method of potency assays and stability studies for cephalexin preparations. The assay was also applied successfully to six different commercial brands and proved to be free of interference from excipients normally used in formulations. Uniformity and dissolution rates were performed on the contents of different brands. The results show that this analytical method can be readily utilized for routine quality control of cephalexin pharmaceuticals because it provides a simple system of analysis consisting of short analytical time which yields reproducible and accurate results.