Seperation and analysis of Amprolium Hydrochloride, vitamin K3, methyl paraben and propyl paraben with HPLC method

Assay analysis and required validation parameters of oral solutions including antiprotozoal effective amprolium HCl, preventing clotting effective vitamin K3 and antimicrobial preservative effective methylparaben and propylparaben which are used to help eliminate malaria disease, kala-azar disease and sleep disease were performed in a simultaneous HPLC method due to its advantage in terms of time. Analysis were carried out at 25°C by using inertsil C8-3 4.6 x 250 mm, 5 µm column, PDA detector set at 254 nm, mobile phase formed of a mixture of heptane-1-sulfonic acid sodium salt, glacial acetic acid, triethylamine and acetonitrile and methanol. Selectivity, system suitability, linearity and accuracy parameters were studied and acceptable results were achieved. Small changes at column temperature and flow rate did not affect the method and this was controlled with the help of the reliability study. Test and standard solutions were observed to be stabil for 90 hours. Keywords: Amprolium hydrochloride, Vitamin K3, Methylparaben, Propylparaben, HPLC validation.