盐酸环喷托酯有关物质测定方法研究

Determination of Related Substances in Cyclopentolate Hydrochloride

建立高效液相色谱法测定盐酸环喷托酯的有关物质。色谱柱为YMC Triart C 8(4.6×250 mm,5μm);流动相A为0.2 mol/L磷酸氢二铵+0.1 mol/L庚烷磺酸钠(磷酸调pH值=3.0),流动相B为乙腈,梯度洗脱;流速1.0 mL/min;检测波长为220 nm;进样体积为20μL;柱温为30℃。在选定的条件下,盐酸环喷托酯与已知杂质A、B、C、E、H分离度良好;杂质A、B、C、E、盐酸环喷托酯分别在0.2171~2.1714,0.2046~2.0465,0.2151~2.1514,0.2022~2.0223,0.2068~2.0683μg/mL浓度范围内线性关系良好;杂质A、B、C、E、盐酸环喷托酯定量限分别为0.0832,0.1121,0.0593,0.0446,0.1017μg/mL;重复性和回收率结果良好。该法专属、准确、易于操作,适用于盐酸环喷托酯有关物质的测定。

The purpose of this study was to establish an HPLC method for the determination of the related substances in Cyclopentolate Hydrochloride.The chromatographic column was YMC Triart C 8(4.6×250 mm,5μm).Mobile phase A was 0.2 mol/L ammonium phosphate with 0.1 mol/L sodium heptanesulfonate(adjusted pH=3.0 with phosphoric acid),and mobile phase B was acetonitrile with gradient elution.The flow rate was 1.0 mL/min;the detection wavelength was 220 nm;the injection volume was 20μL;the column temperature was 30℃.Based on selected condition,the resolutions between Cyclopentolate Hydrochloride peak and kown impurities A,B,C,E,H peaks were fine.Linear range of impurities A,B,C,E and Cyclopentolate Hydrochloride were 0.2171~2.1714,0.2046~2.0465,0.2151~2.1514,0.2022~2.0223,0.2068~2.0683μg/mL,respectively.LOQ of impurities A,B,C,E and Cyclopentolate Hydrochloride were 0.0832,0.1121,0.0593,0.0446,0.1017μg/mL,respectively.Repeatability and recovery of this method were good.This method is specific,accurate and convenient,which applies to analyse the related substances in Cyclopentolate Hydrochloride.