Abstract
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.
Highlights
PCM (PCM; N-[4-hydroxyphenyl] ethanamide; Figure 1b) is a widely used analgesic and antipyretic for the relief of fever, headaches, and other minor aches and pains, and is a major ingredient in numerous cold and flu remedies
DMP is official in Indian Pharmacopoeia where assay is described by titrimetric method
Literature survey revealed that various analytical methods like spectrophotometric [3,4,5,6], HPLC [7,8,9,10,11,12,13,14], GC [15] and high-performance-thin-layer chromatography (HPTLC) [16,17,18,19] have been reported for the determination of Tramadol Hcl (TMD), PCM and either individually or combination with some other drugs, but no HPTLC method was reported for simultaneous estimation of TMD and PCM and domperidol in combined dosage forms
Summary
PCM (PCM; N-[4-hydroxyphenyl] ethanamide; Figure 1b) is a widely used analgesic and antipyretic for the relief of fever, headaches, and other minor aches and pains, and is a major ingredient in numerous cold and flu remedies. This pharmacopoeia suggests titrimetric and UV spectrophotometric assay method for PCM in bulk and tablet formulations. Literature survey revealed that various analytical methods like spectrophotometric [3,4,5,6], HPLC [7,8,9,10,11,12,13,14], GC [15] and HPTLC [16,17,18,19] have been reported for the determination of TMD, PCM and either individually or combination with some other drugs, but no HPTLC method was reported for simultaneous estimation of TMD and PCM and domperidol in combined dosage forms. The review of literature prompted us to develop an accurate, selective and precise simultaneous method for the estimation of TMD, PCM and Domperidol in combined dosage forms
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