HPLC梯度洗脱法测定盐酸利托君的有关物质

Determination of Related Substances in Ritodrine Hydrochloride by Gradient Elution HPLC

目的建立测定盐酸利托君中有关物质的方法。方法采用phenomenex C8色谱柱(4.6 mm×250 mm,5μm),以甲醇-磷酸氢二铵和庚烷磺酸钠混合溶液(磷酸调pH 3.0)为流动相,梯度洗脱,流速1.5 m L/min,检测波长214 nm,柱温35℃。结果高效液相色谱法专属性强,盐酸利托君、盐酸利托君非对映异构体、杂质A约的检测限分别为的2.1 ng,2.5 ng,2.3 ng。结论该方法简便、准确,分离度好,可用于控制盐酸利托君原料的质量。

OBJECTIVE To establish a method for determination the related substances in Ritodrine hydrochloride. METHODS phenomenex C8 （4.6 mm×250 mm, 5 μm）was used. The mobile phase was methanol-Diammonium phosphate and heptane sulfonic acid sodium solution （adjusted to pH 3.0 with phosphoric acid）, gradient elution was used. The flow rate was 1.5 mL/min. The detection wavelength was 214 nm. The column temperature was 35℃. RESULTS The limit of quantification of Ritodrine hydrochloride, Ritodrine hydrochloride-diastereoisomer and impurity A were 2.1 ng, 2.5 ng and 2.3 ng, respectively. CONCLUSION The method was simple, accurate and was good in separable effect. It can be used for quality control of Ritodrine hydrochloride.