Summary

Isolation and Establishment of Curcumin I for Register National Standard Materials

The standard substances play a vital role in assessing quality of active ingredients and finished products. Our country remains too lack the high standards required, especially standard substances from medicinal plants. Therefore, the need to build a quality standard system, reliable, can be used every where in Viet Nam and meet quality requirements of national standards. By column chromatography combine with crystallization method, we have established 11,97 g curcumin I from Curcuma longa L. extract. Additionally, we also evaluated the content of us through three independent laboratories meet ISO/ GLP after closure of each vial 20 mg vials and homogeneity assessment. All assay methods were conducted by HPLC. Statistical evaluation results according to ISO Guide 35 and ISO 13528. Results of vials are homogeneous in the process of packaging and content are more than 98,0% (average results from three laboratories), meet the requirements of national standards.

Keywords: Curcumin I, ISO Guide 35, ISO 13528, ISO Guide 35, between-bottle homogeneity study, interlaboratory comparision, assigned value, z-core.