Simultaneous Estimation of Tramadol Hcl, Paracetamol and Domperidone in Pharmaceutical Formulation by Thin-Layer Chromatographic Densitometric Method

摘要

A simple, precise, rapid, selective, and economic high-performance-thin-layer chromatography (HPTLC) method has been established for simultaneous analysis of Domperidone (DMP), Paracetamol (PCM) and Tramadol Hcl (TMD) in tablet dosage forms. The chromatographic separations were performed on precoated silica gel 60254 plates with toluene-ethylacetate-butanol-ammonia 5:4:1:0.2(v/v) as mobile phase. The plates were developed in a 7.0 cm at ambient temperature. The developed plates were scanned and quantified at their single wavelength of maximum absorption at approximately 278 nm for DMP and PCM, respectively. Experimental conditions such as chamber size, chamber saturation time, migration of solvent front, slit width, etc. was critically studied and the optimum conditions were selected. The drugs were satisfactorily resolved with Rf 0.18 ± 0.02 for DMP, Rf 0.25 ± 0.02 for PCM and for TMD Rf 0.50 ± 0.02. The method was validated for linearity, accuracy, precision, and specificity. The calibration plot was linear between 100-600 ng / band for DMP, 3250-19500 ng/band based for PCM and 375-2250 ng/band based for TMD. The limits of detection and quantification for DMP were 9.95 and 30.16 ng/band, respectively; for PCM they were 64.30 ng and 194.87 ng/band and for TMD 5.51 and 16.70/band. This HPTLC procedure is economic, sensitive, and less time consuming than other chromatographic procedures. It is a user-friendly and importance tool for analysis of combined tablet dosage forms.