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Bioanalytical Method Development and Validation for Simultaneous Determination of Paracetamol, Tramadol HCL, Domperidone Tablet Formulation by RP-HPLC: Its Pharmacokinetic Applications

Abstract

Paracetamol (PAR), Tramadol HCl (TRM) and Domperidone (DOM) used for acute musculoskeletal pain. Method of quantification of low level of these drugs in biological samples is needed to be optimized. Chromatographic separation was achieved on using C18 column by mobile phase composed of Methanol: Phosphate buffer (50:50 v/v) at a flow rate of 1 ml/min and UV detection at 272 nm. In-vivo pharmacokinetic study, blood samples were collected from rats after oral administration of Paracetamol, Tramadol HCl and Domperidone (1 mg/kg). The retention time for Paracetamol, Tramadol HCl and Domperidone was found to be 3.3, 5.3 and 8.9 min, respectively. The results of analysis were validated statically. The linearity range of PAR, TRM and DOM was 250-1500, 25-150 and 25-150 μg/mL, recovered amount of drugs by accuracy was 100.12, 99.87 and 100.4% and tablet analysis was 99.88, 100.28 and 99.6%, respectively. The method was successfully applied to the oral pharmacokinetic study for PAR, TRM, DOM. The maximal concentration (Cmax) of Paracetamol, Tramadol HCl and Domperidone being 156.36, 335.15 and 55.34 (ng/mL) at (Tmax) 3, 4 and 6 and half-life found at 3.75, 5.8 and 4.8 hours, respectively. The current method has been successfully applying to the pharmacokinetic study.

Ramanlal N. Kachave, Ashvini T. Varungase, Pragati B. Mandlik, Snehal R. Wakchaure

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