SIMULTANEOUS ESTIAMATION OF DROTAVERINE HCl AND NIMESULIDE IN PHARMACEUTICALS BY HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHIC METHOD

Abstract

A simple, rapid, precise and accurate high-performance thin-layer chromatographic (HPTLC) method was developed and validated for simultaneous determination of Drotaverine hydrochloride (DRO) and Nimesulide (NIM) in pharmaceutical preparations. Separation was achieved on a Merck HPTLC plates (0.2 mm thickness) precoated with 60 F₂₅₄ silica gel on aluminum sheet as the stationary phase using cyclohexane: methanol: ethyl acetate (5:2.:3v/v/v), as the mobile phase. Densitometric quantification was performed at l = 295 nm by reflectance scanning. The R_F values of DRO and NIM were obtained 0.41 and 0.62 respectively. The linearity of proposed method was investigated in the range of 0.1 to 0.6 mg/spot and 0.2 to 0.7 mg/spot for DRO and NIM respectively.. The percentage recoveries for DRO and NIM were 99.91 % and 100.19 % by area and 99.63 % and 99.96 % by height, respectively. The developed method was suitably validated for precision, accuracy, specificity and ruggedness.