Difference in Nicardipine Degradation Product (L-1) Content among Brand-name and Generic Nicardipine Injection Products

Accession number;05A0182841
Title;Difference in Nicardipine Degradation Product (L-1) Content among Brand-name and Generic Nicardipine Injection Products
Author; OKUBO TADASHI (Hirosakidai I Byoin Chikenkanrise)
Journal Title;Japanese Journal of Pharmaceutical Health Care and Sciences
Journal Code:Y0888A
ISSN:1346-342X
VOL.31;NO.2;PAGE.121-124(2005)
Figure&Table&Reference;FIG.3, TBL.2, REF.10
Pub. Country;Japan
Language;Japanese
Abstract;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% KH2 PO4 (pH 6.5)-CH3OH (25:75, v/v) and the detection wavelength was set at 254nmUV. 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. (author abst.)