Feasibility of the Quality Standard of Potassium Sodium Pehydroandroandrographolide Succinate for Injection / 中国药房

ABSTRACT

OBJECTIVE:To study the feasibility of the quality standard of Potassium sodium pehydroandroandrographolide succinate for injection. METHODS:The contents of dehydroandyograpolide succinate in Potassium sodium dehydroandrograpolide succinate for injection from 13 manufacturers were determined by HPLC and UV spectometry.The related substances of all the samples were determined by HPLC and TLC,respectively. The feasibility of different assaying methods was compared. RESULTS:Determined by HPLC assay,the principal constituent and the degradation products could be separated. There were significant differences between different assaying methods in the determination results of the related substances of samples; TLC assay was inferior to HPLC in respect of the limit of quantitation and accuracy. CONCLUSION:The quality in a few enterprises remains to be improved and the quality standard of Potassium sodium pehydroandroandrographolide succinate for injection remains to be further improved.