應用HPLC方法於Cefadroxil製劑之品質管制   全文下載

Application of HPLC Method for Quality Control of Cefadroxil

在七十九年度發展出抗生素Cefadroxil之高效液相層析法，此法可用於鑑別及測定Cefadroxil原料藥及膠囊製劑之力價，簡單、迅捷且具特異性，可用於取代微生物法來測定Cefadroxil之力價。本實驗乃應用此HPLC方法針對市售之五家不同廠牌Cefadroxil膠囊製劑品質管制之研究，包括容量均一度（Content uniformity），模擬處方試驗之回收率（Recovery）及溶離度試驗（Dissolution test）等。結果顯現不同廠牌製劑之HPLC圖譜，其滯留時間和回收率不會受到製劑賦形劑之影響，顯示此法及分析條件確可應用於藥廠之品質管制。

Our previous study has shown that HPLC method is a suitable substitute for the microbiological method for potency assays and stability studies of cefadroxil preparations. The samples were analysed on µ-Bondapak C18 column with a mobile phase consisting of acetonitrile and phosphate buffer. The assay was also applied successfully to five different commercial brands and proved to be free of interference from excipients normally used in formulations. The contents of unifomity and dissolution rates in different brands were performed. The results have shown that this analytical method could be utilized readily for routine quality control of cefadroxil pharmaceuticals, since it offers a simple system and short analytical time coupled with reproducibility and accuracy.