PURITY AND ASSAY VALIDATION OF PHARMACEUTICAL SUBSTANCE TACALCITOL BY HPLC METHOD
|Anna K. Klein , Barbara Trzpil , Hanna M. Beczkowicz|
Pharmaceutical Research Institute (IF), Rydygiera 8, Warszawa 01-793, Poland
Quality control of pharmaceutical substance is very important and complicated problem because of consequences of propable mistakes during particular analytical determination. Methods used for purity and assay control should be highly specific and precise because of low active substance concentration. Method validation is the process of proving that an analytical method is acceptable for its purpose. During each validation minimum requirements for the method should be set. Checked parameters are, for example: presicion, LOQ, LOD, linearity, selectivity. This work presents tacalcitol purity and assay validation by HPLC - method that is used in routine analysis of this substance. Tacalcitol prevents the excessive growth rate of keratinocytes (a type of skin cells) that leads to scaling of the skin characteristic of psoriasis. Purity and assay validation of this pharmaceutical substance by HPLC, was performed to prove that applied method is highly specific, selective and allows to obtain reliable results.
Presentation: Poster at V Multidyscyplinarna Konferencja Nauki o Leku, by Anna K. Klein
See On-line Journal of V Multidyscyplinarna Konferencja Nauki o Leku
Submitted: 2006-01-31 13:40 Revised: 2009-06-07 00:44