HPLC测定盐酸苯海索中杂质3-苯基-1-(哌啶-1-基)戊-3-醇盐酸盐

Determination of 3-Phenyl-1-(Piperidin-1-yl) Pentan-3-Ol Hydrochloride in Trihexyphenidyl Hydrochloride by HPLC

目的建立高效液相色谱法测定盐酸苯海索中杂质3-苯基-1-(哌啶-1-基)戊-3-醇盐酸盐的含量。方法用十八烷基硅烷键合硅胶为填充剂;以0.1%三乙胺溶液(用磷酸调节pH值至4.0)-乙腈(70∶30)为流动相;检测波长为210 nm;流速为每分钟1.0 mL。结果在此色谱条件下,盐酸苯海索中杂质3-苯基-1-(哌啶-1-基)戊-3-醇盐酸盐分析方法专属性、精密度、耐用性、稳定性均良好。结论经过方法学验证,该方法适用于盐酸苯海索中杂质3-苯基-1-(哌啶-1-基)戊-3-醇盐酸盐含量的测定。

Objective To establish a HPLC method for determination of impurity 3-phenyl-1-(piperidin-1-yl) pentan-3-ol hydrochloride in trihexyphenidyl hydrochloride. Methods A C18 column, 0.1 % triethylamine(adjust with phosphoric acid to a pH of 4.0)-Acetonitrile(70:30) as mobile phase, 210 nm as detection wavelength, and 1.0 mL·min-1 as flow rate were used. Results: The method showed good specificity, precision, durability and stability under above chromatographic condition. Conclusion The method is suitable for the determination of impurity 3-phenyl-1-(piperidin-1-yl) pentan-3-ol hydrochloride in trihexyphenidyl hydrochloride through the methodology validation.