Validated HPTLC Method for simultaneous quantitation of Paracetamol, Tramadol and Aceclofenac in tablet formulation

 

By Prafulla. P. Apshingekar, Mahadev. V. Mahadik and Sunil. R. Dhaneshwar 

ABSTRACT

This paper describes a new, simple, precise, and accurate HPTLC method for simultaneous quantitation of Paracetamol (PARA), Tramadol (TRA) and Aceclofenac (ACF) as the bulk drug and in tablet dosage form. Chromatographic separation of the drugs was performed on aluminum plates precoated with silica gel 60 F254 as the stationary phase and the solvent system consisted of toluene: ethyl acetate: formic acid 7: 2: 0.5 (v/v/v). Densitometric evaluation of the separated zones was performed at 261 nm. The two drugs were satisfactorily resolved with RF values 0.19 ± 0.02, 0.40  ±0.02 and 0.53 ± 0.02 for PARA, TRA and ACF, respectively. The accuracy and reliability of the method was assessed by evaluation of linearity (487.5–2437.5 ng.spot-1 for PARA, 56.25-281.25ng.spot-1 and 150-750 ng.spot-1 for ACF), precision (intra-day RSD 0.39-1.95 % and inter-day RSD 0.56–1.88 % for PARA, and intra-day RSD 1.02-1.92 % and inter-day RSD 1.11–1.91 % for TRA and intra-day RSD 1.80-1.99 and inter day RSD 0.90-1.97 % for ACF), in accordance with ICH guidelines.  

Keywords: Thin layer Chromatography, Densitometry, Validation and Quantification, Paracetamol, Tramadol and Aceclofenac

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