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

Abstract

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.

 

Related papers
  1. Problems of determination of selected Class 1 residual solvents (according to ICH*)) as process impurities of some Class 3 and 2 solvents in API by GC-HS method
  2. The Crystal Structure of distrontium salt of 5-[bis(carboxymethyl)amino]-3-carboxymethyl-4-cyano-2-thiophenecarboxylic acid
  3. QUINONES AND HYDROQUINONES SEPARATION AND DETERMINATION BY HPLC CHROMATOGRAPHY
  4. CHARACTERIZATION OF ARIPIPRAZOLE SOLVATE WITH ETHANOL AND POLYMORPHIC FORMS PRODUCED DURING ITS HEATING
  5. SYNTHESIS OF GLIMEPIRIDE - CRYSTAL STRUCTURE ANALYSIS STEP BY STEP
  6. THE COMPARISON OF TWO VALIDATED HPLC METHODS FOR THE DETERMINATION OF (+)-CLOPIDOGREL HYDROGENSULFATE PURITY WITH THE USP METHOD.

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