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   全文下載

High Performance Liquid Chromatography Analysis of Tetrahydrozoline Hydrochloride in Ophthalmic Solution by Silica Column Eluted with Aqueous Solvent Mixtures

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。回收率範園為98.9 to 99.9%。在線性範圍為12.5到500 μg／mL （r2 = 0.9996）和1.0到20μg／mL （r2 =0.9997）時均呈良好線性關係。本研究方法堪稱簡便迅捷，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間，充分節省分析時間，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。"

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. 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。回收率範園為98.9 to 99.9%。在線性範圍為12.5到500 μg／mL （r2 = 0.9996）和1.0到20μg／mL （r2 =0.9997）時均呈良好線性關係。本研究方法堪稱簡便迅捷，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間，充分節省分析時間，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。