Determination of Levidipine and Related Substance by RP￣HPLC / 医药导报

ABSTRACT

Objective To develop a reversed phase high performance liquid chromatography ( RP￣HPLC) method determining the related substances and levidipine. Methods The Welchrom C18 column (250 mm×4.6 mm,5 μm) was used with Octadecylsilane bonded silica as a filler.The mobile phase consisted of methanol￣ethanol￣water (40:20:40),at the flow rate of 1 mL.min-1 in an isocratic elution,the temperature was at 45 ℃ , and the detective wavelength was 240 nm. Results Levidipine could be separated from all impurities and intermediates within the concentration range from151 to 604 ng.mL-1 , which had a satisfied linear relationship (r= 0.999 9) with a regression equation of Y= 0.049 9X+0.597 9.The LOQ of detection was 31.9 ng.mL-1 . Conclusion The developed method is specific,sensitive,easy and fast to operate,which is suitable for detecting levidipine and its related impurities.