SIMULTANEOUS ESTIMATION AND VALIDATION OF VARDENAFIL AND DAPOXETINE HYDROCHLORIDE IN PHARMACEUTICAL FORMULATION BY THIN LAYER CHROMATOGRAPHIC DENSITOMETRIC METHOD

Abstract

The present manuscript describes new, simple, accurate, and precise high performance thin layer chromatography method for the simultaneous determination of Vardenafil and Dapoxetine in combined tablet dosage form. Chromatographic separation of the drugs was performed on aluminium plates pre coated with silica gel 60 F254 as the stationary phase and the solvent system consisted of Chloroform: Methanol: Acetonitrile: Formic acid (4: 0.8: 4: 1 v/v/v/v). Densitometric evaluation of the separated zones was performed at 232 nm. The two drugs were satisfactorily resolved with Rf values 0.47 and 0.79 for Vardenafil and Dapoxetine Hydrochloride, respectively. The linear regression data for the calibration plots showed good relationship with r² = 0.9995 from 150-750 ng/spot for Vardenafil and r² = 0.9980 from 450-2250 ng/spot for Dapoxetine Hydrochloride. The methods were validated for precision, accuracy, and recovery. The percentage recovery for Vardenafil was found to be 99.58 – 100.72 % and 99.97 – 100.21% for Dapoxetine Hydrochloride. The limits of detection and quantification were 21.86 and 66.25 ng/spot per spot for Vardenafil and 128.58. and 389.64 ng/spot per spot for Dapoxetine Hydrochloride, respectively.