HPLC法测定盐酸卡替洛尔滴眼液有关物质

Determination of related substances of carteolol hydrochloride eye drops by HPLC

目的:建立高效液相色谱法(high performance liquid chromatography,HPLC)测定盐酸卡替洛尔滴眼液中有关物质的方法,提高盐酸卡替洛尔滴眼液的质量标准。方法:采用HPLC法,色谱柱为ODS C18(250 mm×4.6 mm,5μm),流动相为甲醇-乙腈-2.82 g·L^-1己烷磺酸钠溶液(10∶200∶790);流速为1.0m L·min^-1;柱温为30℃;检测波长为252 nm;进样量为20μL。结果:盐酸卡替洛尔与杂质H分离度良好,杂质H在0.02~20.0μg·m L^-1范围内,与色谱峰峰面积呈良好线性关系(r=1.0000),杂质H校正因子为0.62。利用该方法对盐酸卡替洛尔进行加速和长期稳定性试验,均在合格范围内,未发生显著变化。结论:该方法可靠有效、灵敏度高、检测快速,可用于盐酸卡替洛尔滴眼液有关物质的检测。

Objective:To establish a method for the determination of related substances in carteolol hydrochloride eye drops by high performance liquid chromatography(HPLC)and improve the quality standards of the eye drops.Methods:HPLC method was developed with ODS C18(250 mm×4.6 mm,5μm)as the chromatographic column and eluted at a flow rate of 1.0 mL·min^-1 with mobile phase consisting of methanol-acetonitrile-2.82 g·L^-1 sodium hexane sulfonate solution(10∶200∶790).The column temperature,detection wavelength and the injection volume were set at 30℃,252 nm and 20μL,respectively.Results:Carteolol hydrochloride and impurity H were completely separated.The impurity H showed a good linear relationship with the peak area of the chromatogram in the range of 0.02~20.0μg·mL^-1(r=1.0000).The correction factor of impurity H was 0.62.The acceleration and long-term stability tests of carteolol hydrochloride eye drops were carried out using the developed method.All the results were within the qualified range and no significant change was observed.Conclusion:The method is reliable,effective,high sensitive,fast detectable and can be used to detect related substances of carteolol hydrochloride eye drops.