Valdation Chromatographic Quantitative Determination of N-Nitrosodimethylamine And N-Nitrosodiethylamine Impurities In “Valsacor Hd” Tablets

Abstract

Chromatographic (HPLC) method for determination of NDMA and NDEA impurities in “Valsacor HD” tablets.

The coefficient of variation specificity is 0,03 for NDMA and 0,02 for NDEA(CV≤2%).

The accuracy (systematic error of an analytical method) for the NDMA is - 0,172 and for NDEA - 0,58% (acceptability criteria ≤2,0%);

The correlation coefficient for the NDMA is - 0,997 and for NDEA - 0,999% (N>0,995); The method is linear from 5/5 ng/ml - 250/250 ng/ml.

Thus, the results received during validation of an HPLC method of quantitative determination of NDMA and NDEA impurities in “Valsacor HD” tablets, have shown full conformity of the developed method to requirements Guidance for Industry Bioanalytical Method Validation U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Veterinary Medicine (CVM) May 2001 on the following validation characteristics: Specificity, Accuracy.