梯度洗脱HPLC法测定盐酸替扎尼定片有关物质

Determination of Related Substances of Tizanidine Hydrochloride tablets by HPLC Gradient Elution

目的建立梯度洗脱HPLC法测定盐酸替扎尼定片中的有关物质。方法采用Symmetry C18(5μm,250mm×4.6mm)柱,流动相A为乙腈-0.02mol·L-1戊烷磺酸钠液(20∶80,V/V),用磷酸调至pH 3.0,流动相B为乙腈,梯度洗脱,流速为1.0mL·min-1,检测波长为230nm。结果各有关物质分离良好,替扎尼定在0.23～56.27μg·mL-1之内线性关系良好(r=0.9999),检测限为0.01μg·mL-1。结论该方法简便、灵敏、准确,可用于本品的质量控制。

OBJECTIVE To develop a method for the determination of related substances in tizanidine hydrochloride tablets. METHODS The liquid chromatography was carried out using a Symmetry C18 column （5μm,250mm×4.6mm）. The mobile phase A was consisted of acetonitrile-0. 02mol · L^-1 solution of 1-Pentane sulfonic acid sodium salt （20：80 ,V/V） ,adjusted to pH = 3.0 by phosphoric acid,The mobile phase B was acetonitrile, gradient elution. The flow rate was 1mL · min^-1. The detection wavelength was 230nm. RESULTS Related substances could be separated. The calibration curve of tizanidine was linear in the range of 0. 23～56. 27μg·mL^-1. The detection limit was 0. 01 μg·mL^-1. CONCLUSION The method is simple, sensitive, accurate, and can be used for quality control of tizanidine hydrochloride tablets.