Abstract

DEVELOPMENT AND VALIDATION OF METHOD FOR DETERMINATION OF LUTEIN BY HPLC

*Md. Habib Ullah Bhuyian, A.F.M. Ariful Islam, Md. Isha Tareque, Dr. Harun Ar Rashid

Abstract

A simple selective and rapid reversed phase high performance liquid chromatographic (RP-HPLC) method for The analysis of Lutein 5% has been developed and validated. The separation was achieved from HPLC Column ( C18 250mm x 4.6 mm, 5 μm) with a mobile phase Acetonitrile, Methanol, Water and Ethyl Acetate in the ratio of 70:9·6:0.4:20. Flow rate 1.0 ml/min with UV-visible detection at 446 nm. The method is specific and it is observed that no interference with diluents. Proposed method is accurate with (99.89%-100.16%) recovery for Lutein. The proposed method was accurate, and precise for the quantification of Lutein 5%. The proposed can also be used for routine analysis in quality control. The method was validated for parameters like selectivity, sensitivity, precision, intermediate precision, accuracy, linearity, recovery & stability. This (RP-HPLC) method is suitable for determining the concentration of Lutein 5% and it can apply for routine analysis for determination of the Lutein from dosage form.

Keywords: HPLC Column, Carotenoids, Zeaxanthin FDA, ICH, ?-carotene.