Abstract

ANALYTICAL METHOD DEVELOPMENT FOR IMPURITIES PRESENT IN HYDROXY CHLOROQUINE SULPHATE FROM ANTIMALARIAL TABLET FORMULATION

SP. Karuppiah*, K. Anver Basha

ABSTRACT

The study reveals that stability indicating analytical method development for the estimation of Impurities present in Hydroxy chloroquine Sulphate (HCS) from anti malarial tablet formulation.The developed method is specific,linear,accurate,robust and can be used for regular analysis. The known impurities are identified and estimated quantitatively as i) Hydroxy Chloroquine –O-Sulphate (HCOS) ii)4,7-Dichloroquinoline (4,7 DCQ) iii)Desethyl Hydroxy Chloroquine (DEHC) iv) Desethyl Chloroquine (DEC) by RP-HPLC method.The Relative Response Factor(RRF) and Relative Retention Time (RRT) has established for the quantification of impurities without using known impurities every time. Gradient elution has set up in proper proportion with buffer: methanol (90:10) and acetonitrile (100%) in two different channels using Inertsil C8-3 (150 X 4.6), 5μm column in a detection wavelength of 380 nm. The range is covered from 50% to 150% of working concentration of 2ppm which is the range of Hydroxy chloroquine sulphate tablets 200 mg. The recovery study of each impurity is carried out and the result obtained is well within acceptance criterion of 90% to 110%.

Keywords: Hydroxy chloroquine sulphate, impurity profiling, Hydroxy Chloroquine –O-Sulphate, 4,7-Dichloroquinoline, Desethyl Hydroxy Chloroquine, Desethyl Chloroquine.