應用HPLC方法於Dicloxacillin製劑之品質管制

Application of HPLC for Quality Control of Dicloxacillin

范燕珍(Yann-Jen Fann) ； 許美智(Mei-Chich Hsu)

《藥物食品檢驗局調查研究年報》 9號 (1991/09) Pp. 105-110

https://doi.org/10.6946/ASRNL.199109.0105

摘要

本局於七十八年度發展出一種高效液相層析法，可用於鑑別及州定Dicloxacillin原料藥及膠囊製劑之力價。使用μ-Bondapak C18為層析管，以甲醇與4%醋酸(60:40)之混合液為移動相，dimethylphthalate為內部標準品，終254nm波長處紫外光偵測器測之。由於同時以HPLC法與微生物法作配對實驗測定力價，並用paired-t test作配對比較，結果証明Dicloxacillin原料藥及膠囊製劑以二種方法測定所得之力價並不具統上之差異。亦即HPLC法可用以取代微生物法來測定Dicloxacillin各製劑之力價。故本實驗乃應用此HPLC方法於市售四家不同廠牌Dicloxacillin膠囊製劑之品質管制。包括容量均一度(Content uniformity)，模擬處方試驗(Recovery)及溶離度試驗(Dissolution test)等。本方法簡單，迅捷且具特異性。

並列摘要

A reversed phase high performance liquid chromatographic method has been developed for the assay of dicloxacillin. The samples were analysed on a μ-Bond apak (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 for potency assays and stability studies of dicloxacillin preparations.
The assay was also applied successfully to four different commercical brands and proved to be free of interference from excipients normally used in formulations. The contents of uniformity 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 dicloxacillin pharmaceuticals, since it offers a simple system and short analytical time coupled with reproducibility and accuracy.