Abstract

DEVELOPMENT AND VALIDATION OF RP- HPLC METHOD FOR THE DETERMINATION OF IBUPROFEN AND TRAMADOL IN PHARMACEUTICAL DOSAGE FORM

Sunitha Banothu*, Keesara Pushpalatha and Deepa Kantekar

ABSTRACT

A simple and selective LC method is described for the determination of IBUPROFEN and TRAMADOL in tablet dosage forms. Chromatographic separation was achieved on a c18 column using mobile phase consisting of a mixture of 30 volumes of acetonitrile and 50 volumes of Methanol and 20 volumes of water with detection of 227nm. Retention time of ibuprofen was 2.440 and tramadol was 5.503. Linearity was observed in the range 5-15μg /ml for IBUPROFEN (r2 =0.993) and 5-15μg /ml for TRAMADOL (r2 =0.992) for the amount of drugs estimated by the proposed methods was in good agreement with the label claim. The proposed methods were validated. The accuracy of the methods was assessed by recovery studies at three different levels. Recovery experiments indicated the absence of interference from commonly encountered pharmaceutical additives. The method was found to be precise as indicated by the repeatability analysis, showing %RSD less than 2. All statistical data proves validity of the methods and can be used for routine analysis of pharmaceutical dosage form.

Keywords: Tramadol, ibuprofen, acetonitrile, methanol, retention time, linearity.