Application of HPLC and HPTLC-Densitometry for the Simultaneous Determination of Camylofin and Diclofenac in Pharmaceutical Dosage Form

Simple and accurate liquid chromatographic (HPLC) and thin layer chromatographic (HPTLCdensitometry) methods for simultaneous determination of camylofin dihydrochloride (CAM) and diclofenac potassium (DIC) in tablets were elaborated. The first method was based on isocratic reversed phase liquid chromatography by using RP ODS-C18 column with a mobile phase consisting of acetonitrile:25mM potassium dihydrogen phosphate (80:20, v/v) containing 0.1% v/v acetic acid adjusted to pH 7 with triethylamine at a flow rate of 1.5 mL/min and UV detection at 215 nm. The calibration curve of camylofin and diclofenac was linear in the range of 50-300 μg/mL (r>0.999) and 5-30 μg/mL (r>0.999), respectively. The second thin layer chromatographic method employed by using pre-coated silica gel G60–F254 aluminum sheet using mobile phase chloroform:ethyl acetate:methanol:ammonia (5:3:2:0.1,v/v) and quantitation was achieved using spectrodensitometrically at 215 nm. The calibration curve of camylofin and diclofenac was linear in the range of 1500-9000 ng/spot (r>0.999) and 150-900 ng/spot (r>0.999), respectively. The validity of the methods was confirmed using the recovery studies, precision and limit of detection. Both techniques were applied successfully for the analysis of camylofin and diclofenac in tablets form. The results obtained from both procedures were statistically compared using the Student’s-t and F-variance ratio tests.