STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF OXYCODONE AND IBUPROFEN IN BULK AND ITS DOSAGE FORMS

Abstract

A Stability indicaiting, simple, sensitive and rapid reverse phase high performance liquid chromatographic method
was developed for the estimation of Oxycodone and Ibuprofen in Bulk and its dosage forms. The isocratic method
was developed on Inspire C18 (4.6x150 mm,5 µm) column with potassium dihydrogen orthophosphate buffer ( pH
3.0):Acetonitrile mobile phase in ratio of 35:65 delivered at 0.8 ml/min and effluents were monitored at 220 nm. The
mobile phase was used as a diluent. The Injection volume was 20 μl. The analytical procedure was validated as per
ICH guidelines. The selected chromatographic conditions were found to separate Oxycodone (Rt=3.9 min) and
Ibuprofen (Rt=2.96 min).Calibration curve was plotted with a range from 4.0 -6.0 µg/ml and 320-480 µg/ml for
Oxycodone and Ibuprofen respectively. Results of the analysis were statistically as per ICH guidelines. The
percentage recoveries for Oxycodone and Ibuprofen ranged from 99.82% and 99.85 % respectively. The limit of
detection was found to be 3.05µg/ml and 3.14µg/ml for Oxycodone and Ibuprofen respectively. Limit of
quantification was found to be 9.95µg/ml and 10.02 µg/ml for Oxycodone and Ibuprofen respectively. The method
represents a fast-analytical procedure and stability indicating analytical method for the simultaneous estimation of
Oxycodone and Ibuprofen in bulk and its dosage forms. No interference from any component of pharmaceutical
dosage form was observed. Validation studies revealed that the method is specific, rapid, reliable, and reproducible.
The method is amenable to the routine analysis of large numbers of samples with good precision and accuracy