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ABSTRACT:
Simple, accurate, precise, and sensitive reversed-phase high-performance liquid chromatographic (RP-HPLC) method for simultaneous estimation of Paracetamol (PCM), Tramadol and Aceclofenac in the presence of its degradation products, have been developed and validated by LC/MS. Linearity of PCM, TRA and ACL was obeyed in concentration range 2-30, 2-14 and 2-35 µ g/ml in Acetonitrile: Phosphate buffer (pH 3.4, 20:80 v/v) as the mobile phase at 270 nm, respectively. The detection was carried out using a diode array detector set at 270 nm. Linearity of the LC method was in the concentration range of 2-10 µ g/mL for PCM, TRA and ACL respectively. The recoveries were in the range of 99.49 ± 0.74 to 100.08 ± 0.1 for PCM, 99.36 ± 0.73 to 100.05 ± 0.10 for TRA and 98.42 ± 0.96 to 101.04 ± 0.49 for ACL in RP-HPLC. RP-HPLC method has been successfully applied for the analysis of the drugs in a pharmaceutical formulation in the presence of its degradation products. Results of analysis were validated statistically. Degradation study was performed under different conditions using same RP-HPLC method and method was revalidated for simultaneous estimation in presence of their degradation products and confirmed by LC/MS.
KEYWORDS HPLC, Paracetamol, Tramadol, Aceclofenac, Validation, Degradation, Mass spectroscopy
INTRODUCTION:
Paracetamol (PCM) is chemically known as N-(4-hydroxyphenyl)acetamide and belongs to the class of compounds known as NSAID,1-3 and also having antipyretic action. Its action mediates through cyclo-oxygenase-3 inhibition and modulation of central serotonergic pathways. Aceclofenac (ACL) is chemically known as 2-[2-[2-(2,6-Dichlorophenyl) aminophenyl]acetyl]oxyacetic acid. ACL is phenylacetoxyacetic acid, is a novel non-steroidal anti-inflammatory drug. Aceclofenac inhibited interleukin-1β-induced prostaglandin E2 production by human rheumatoid synovial cells, but had no inhibitory effect on cyclooxygenase-1 or cyclooxygenase-2 activities by itself. Tramadol (TRA) is chemically known as (1R, 2R)-rel-2-[(dimethylamino) methyl]-1-(3-methoxyphenyl) cyclohexanol.
TRA is a µ-opioid receptor agonist, serotonin releasing agent, norepinephrine reuptake inhibitor, NMDA receptor antagonist, 5-HT2C receptor antagonist (α7)5 nicotinic acetylcholine receptor antagonist, and M1 and M3 muscarinic acetylcholine receptor antagonist. The analgesic action of tramadol has yet to be fully understood, but it is believed to work through modulation of serotonin and norepinephrine in addition to its mild agonist of the µ-opioid receptor. The chemical structures of PCM, TRA and ACL are shown in Figure 1.
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