RP-HPLC-METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF DEXKETOPROFEN TROMETAMOL AND TRAMADOL HYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORM
Keywords:Reverse phase-high performance liquid chromatography, Validation, Dexketoprofen trometamol, Tramadol hydrochloride
Objective: For the measurement and quantification of Dexketoprofen Trometamol and Tramadol Hydrochloride, a rapid, sensitive, and reliable RP-HPLC technique using the Waters HPLC System with PDA detection was designed and validated.
Methods: Chromatography was carried out on an Inertsil-ODS C18 (250 x 4.6 mm, 5) column with a flow rate of 1.0 ml/min and effluent of 240 nm using filtered and mixed Degassed Methanol: Buffer (75:25) v/v as a mobile phase.
Results: Dexketoprofen Trometamol and Tramadol hydrochloride has a retention time of 3.617 min and 5.013 min, respectively. % recovery for Dexketoprofen trometamol and tramadol hydrochloride was found to be 100.21% and 100.20%, respectively. LOD and LOQ values obtained for Dexketoprofen trometamol and tramadol hydrochloride are 0.074µg/ml, 0.225µg/ml and 0.175µg/ml, 0.531µg/ml respectively. Regression equation of Dexketoprofen trometamol is y = 7446.1273x-284.0702 and y = 39535.8782x-1580.4211 of Tramadol hydrochloride.
Conclusion: Dexketoprofen trometamol and tramadol hydrochloride has developed and validated in pharmaceutical dosage form using RP-HPLC method.
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