ニカルジピン注射製剤の先発医薬品と後発医薬品中のニカルジピン分解物 (L-1) 含有量の違いに関する研究

Using high performance liquid chromatography (HPLC), the author determined the content of nicardipine degradation product (L-1) in brand-name and generic-name nicardipine injection products. The mobile phase consisted of 0.25 % KH2PO4 (pH 6.5) -CH3OH (25 : 75, v/v) and the detection wavelength was set at 254 nmUV. A separate peak for L-1 was identified by using reference standard compounds. Several products of nicardipine injection on the Japanese market were analysed and the L-1 contents varied among them. Through this study, we found that there were differences in quality between the brand-name and generic nicardipine injection products, and that there were also differences in quality among the individual generic products.