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題名 | High Performance Liquid Chromatography Analysis of Tetrahydrozoline Hydrochloride in Ophthalmic Solution by Silica Column Eluted with Aqueous Solvent Mixtures=於矽膠層析管以含水性移動相分析定量眼藥水製劑中Tetrahydrozoline Hydrochloride成分 |
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作者 | 黃明權; 何秀娥; 溫國慶; 許明照; | 書刊名 | 藥物食品分析 |
卷期 | 10:2 2002.06[民91.06] |
頁次 | 頁88-94 |
分類號 | 418.2323 |
關鍵詞 | 眼用製劑; 定量分析; 高效液相層析法; Tetrahydrozoline; Ophthalmic solution; Analysis; HPLC; Silica column; |
語文 | 英文(English) |
中文摘要 | 本研究利用高效液相層析法,以矽膠層析管分析,定量眼藥製劑中Tetrahydrozoline Hydrochloride成分。移動相為甲醇/水溶液(7:3,v/v)含Triethylamine 0.03% (v/v)及Acetic acid 0.02% (v/v),檢測波長為254nm,流速1 mL/min,結果良好。回收率範圍為98.9 to 99.9%。在線性範圍為12.5到500 μg/mL(r2 = 0.9996)和1.0到20 μg/mL (r2 = 0.9997)時均呈良好線性關係。本研究方法戡稱簡便迅捷,可解決以HPLC方法定量鹼性藥品常見Tailing及滯流時間長之缺點,並可有效節省移動相配製、層析管及儀器管道清洗時問,充分節省分析時問,同時由於移動相不添加任何鹽類,更能避免儀器因鹽析而阻塞或損害。 |
英文摘要 | A HPLC method using bared silica column eluted with aqueous solvent mobile phase was developed for determination of tetrahydrozoline hydrochloride in ophthalmic preparations. A mixture of methanol and water (70:30, v/v) containing 0.03% triethylamine and 0.02% acetic acid was used as mobile phase, and chlorpheniramine maleate as an internal standard. The flow rate was 1 mL/min and the detection was at 254 nm. The quantitation limit was 1.0 μg/mL. Average recoveries range from 98.9 to 99.9%. The linearity of the calibration curve of tetrahydrozoline hydrochloride was well correlated (r2 = 0.9996) within the range from 12.5 to 500 μg/mL as well as from 1.0 to 20 μg/mL (r2 = 0.9997). This study further reports a simple and quick method for routine quantitative analysis of tetrahydrozoline hydrochloride in an ophthalmic solution that contains a relatively high concentration of sulfamethoxazole sodium and methyl paraben. |
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