Abstract

Validated HPTLC method for simultaneous estimation of Rabeprazole Sodium, Paraetamol and Aceclofenac in bulk drug and formulation

Author(s): Vishal V Bharekar, Toufik S Mulla, Milind P Rajput, Savita S Yadav, Janhavi R Rao

This paper describes a new, simple, precise, and accurate HPTLC method for simultaneous estimation of Rabeprazole sodium, Paracetamol and Aceclofenac as the bulk drug and in tablet dosage forms. 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: methanol: acetic acid 6: 4: 0.8: 0.4 (v/v/v/v). Densitometric evaluation of the separated zones was performed at 256 nm. The three drugs were satisfactorily resolved with RF values 0.35 ± 0.5, 0.42 ± 0.3 and 0.57 ± 0.42 for Rabeprazole sodium, Paracetamol and Aceclofenac respectively. The accuracy and reliability of the method was assessed by evaluation of linearity 100–200 ng/spot for Rabeprazole sodium, 15–90 ng/spot for Paracetamol and 12-72 ng/spot for Aceclofenac., precision (intra-day RSD 1.66–1.87 % and inter-day RSD 1.48–1.60 % for Rabeprazole sodium , and intra-day RSD 1.03–1.74 % and inter-day RSD 0.53–1.59 % for Paracetamol similarly intra -day RSD 1.12–1.73 % and inter-day RSD 0.62–1.73 % for Aceclofenac ), accuracy (100.25 ± 0.12 % for Rabeprazole Sodium, 99.67 ±0.06 % for Paracetamol and 99.63 ± 0.18 % for Aceclofenac), and specificity, in accordance with ICH guidelines.

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