DETERMINATION OF DIFFERENT SOLUBILITY VITAMINS IN PHARMACEUTICAL PREPARATIONS. II. METHODS VALIDATION

Abstract

ABSTRACT Validation of methods for quantitative determination of vitamins in multivitamin preparations was performed. It was confirmed that tested methods are suitable for determination of both nonpolar vitamins (fat-soluble: A, D3 and E) and polar vitamins (water-soluble: B1, B2, B6, C, and PP). Determinations were quick and selective; they allowed a separation of peaks of vitamins to the baseline within 25 minutes. The ranges of concentration taken through the validation procedure were similar to daily doses of vitamins proposed by the Food and Drug Administration (FDA), and they were within the range of vitamin concentrations in common pharmaceutical preparations. In these ranges of concentration, the calibration graphs were linear (correlation coefficient r from 0.990 to 0.999). The repeatability of the methods (RSD) varied between 1.4 and 4.5% for fat-soluble vitamins and between 1.6 and 2.6% for water-soluble vitamins. The recoveries of added vitamins were between 98.1 and 100.4% for fat-soluble vitamins, and 97.2 and 99.0% for water-soluble vitamins. The sample solutions were stable for twenty-four hours after the preparation. The obtained results show that these methods are usable for automatic quantitative determination of vitamins in pharmaceutical preparations for quality control purposes.