DEVELOPMENT AND VALIDATION OF HPLC AND HPTLC METHODS FOR DETERMINATION OF CINNARIZINE AND DOMPERIDONE MALEATE IN COMBINATION

Abstract

Rapid, accurate and sensitive methods for the identification and quantification of Cinnarizine (CINN) and Domperidone maleate (DOM) were developed by HPTLC-densitometry and HPLC at 270 nm. The first developed method was HPTLC, where mixture of Cinnarizine and Domperidone maleate were separated on silica gel TLC 60 F254 plates using absolute Benzene:Tolune:Methanol (5.5:3:1.5 v/v/v) as mobile phase and scanning of the separated bands at 270 nm. Linearity was observed in the concentration range of 0.5-1.0 µg/band for both the drugs. The second method was HPLC, where the mixture of Cinnarizine and Domperidone maleate separated on thermo scientific MOS-I hypersil C8 column (5µm p.s, 150 mm  4.6 mm), column temperature 25oc, flow rate 1 ml/min. The mobile phase selected was Acetonitrile : Ammonium acetate (50 mM) (78:22 v/v) with detection at 270 nm. Linearity was observed in the concentration range of 40-280 µg/ml for Cinnarizine and 30-210 µg/ml for Domperidone maleate. Both methods were validated according to ICH guideline and value of linearity, precision, robustness, LOD, LOQ, selectivity, recovery were found to be in good accordance with the prescribed value.