Friday , 24 May 2024

Analytical Method Development and Validation of Simultaneous Estimation of Tramadol, Paracetamol, Domperidone in Tablet Dosage Form by RP-HPLC

Nagaraju.Y*, A. Ajitha and Uma Maheshwar Rao. V
Departmentof Pharmaceutical Analysis, CMR College of Pharmacy, Ranga Reddy-501401, India

A simple reverse phase high pressure liquid chromatography (RP-HPLC) method has been developed and validated for simultaneous estimation of tramadol paracetamol and domperidone in tablet dosage forms. The compounds were separated on inertsil C-18 ODS column with mixture of phosphate buffer (pH-6.0 adjusted with o-phosphoric acid): methanol in the ratio 80:20v/v at flow rate 0.8ml/min. UV detection was 278nm. The method was validated for accuracy, precision, specificity, linearity and sensitivity. The developed and validated method was successfully used for analysis of TRAM-PD tablets. Total run time for analytes was nearly 10min with Tramadol, Paracetamol and Domperidone eluting with retention time 6.2, 3.7, 7.7 mins respectively. Validation studies showed the method is specific, reliable and reproducible. Calibration plots were linear over the concentration range 3.75-11.25µg/ml for tramaddol, 32.5-97.5µg/ml for paracetamol and 1-3µg/ml for domperidone. The LOD and LOQ were 0.36, 5.44, 0.08 and 1.08, 16.49, 0.24 respectively.
Keywords: RP-HPLC, Octa Decyl Silane, Tramadol HCl, Paracetamol, Domperidone

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