本研究是建立timolol及betaxolol等貝他阻斷劑之眼藥水中所含藥物的分析方法,並進行製劑的安定性研究。在此研究中,二種貝他阻斷劑的HPLC分析是使用逆相的C-18管柱,檢品中並含Nadolol作為内在標準品。在此分析條件下,内在標品及二種藥物(Nadolol,Timolol及Betaxolol)的滯留時間分別為4.3,6.2及14.8 min。此分析法再經由光偶陣列檢測器加以評估,顯示此三種貝他阻斷劑,並未受到眼藥中添加物的干擾。目前最常用於眼藥製劑的抑菌劑是Benzalkonium Chloride(BKC),在以往藥典規定是由抑菌的效果來評估BKC的濃度,但在此研究中我們也建立該藥物在製劑中含量的HPLC分析方法。其分析是採用逆相的CN管柱並在檢品中加入Cetylpyridinium Chloride作為内在標準品。所得到HPLC的BKC分析圖譜顯示其所C12H25及C14H29兩種不同烷基成份的滯留時間分別是11.2及16.0 min。而使用此分析法,當檢品稀釋10倍或更多時,在含低濃度添加物時也不會干擾到分析結果。在製劑的安定性研究,Timolol及Betaxolol製備成眼藥水,内含聚乙烯醇或甲基纖維素及緩衝劑等並調整pH值至8左右,此組合物也具有良好的安定性,但更進一步的安定性研究則仍在進行中。
The analytical method of timolol and betaxolol in opthalmics was developed and established in this study. In addition, the stability tests of the eye drops for these two beta-blockers were also investigated. Two beta-blockers were determined in an HPLC system by using a reverse-phase C-18 column with an internal standard nadolol. The retention times were 4.3, 6.2 and 14.8 min for nadolol, timolol and betaxolol, respectively. The analytical method was further evaluated by the photodiode array detector. It was demonstrated that the HPLC assay method was not interferred by the additives of ophthalmic preparations such as polymers or buffer. Benzalkonium chloride (BKC) is the major antiseptic agent of eye drops. In this study, we also established an HPLC analytical method to determine the content of BKC in ophthalmics that may substitute for the pharmacopeial method to evaluate the antimicrobiological effect of BKC. The antiseptic agent was determined in a CN reverse-phase column with an internal standard cetylpyridinium chloride. The HPLC profiles showed two components of BKC with retention times 11.2 and 16.0 min, respectively, for alkyl group C12H25 and C14H29. This analytical method was not interfered by the excipients of ophthalmics in 10-fold diluted samples. For the stability study, timolol and betaxolol were prepared as eye drops containing polyvinyl alcohol or methyl cellulose and buffer, and adjusted to pH 8. These formulations were shown to have good stability in the preliminary studies. However, the stability test need further investigation.
為了持續優化網站功能與使用者體驗,本網站將Cookies分析技術用於網站營運、分析和個人化服務之目的。
若您繼續瀏覽本網站,即表示您同意本網站使用Cookies。