High Performance Liquid Chromatography Analysis of Tetrahydrozoline Hydrochloride in Ophthalmic Solution by Silica Column Eluted with Aqueous Solvent Mixtures
MING-CHUAN HUANG 1,2, HSIU-O HO 1, KUO-CHING WEN 2 AND MING-THAU SHEU 1*
1. Graduate Institute of Pharmaceutical Sciences, Taipei Medical University, 250 Wu-Hsing Street, Taipei, 110, Taiwan, R.O.C.
2. National Laboratories of Foods and Drugs, Department of Health, Executive Yuan, 161-2, Kuen Yang St., Nankang, Taipei 115, Taiwan, R.O.C.
(Received: July 5, 2001; Accepted: February 5, 2002)
ABSTRACT
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.
Keywords: tetrahydrozoline, ophthalmic solution, analysis, HPLC, silica column