Development and validation of a RP-HPLC for simultaneous determination of Ibuprofen and Paracetamol in solid dosage forms: Application to dissolution studies

Abstract

A reverse phase high performance liquid chromatographic (RP-HPLC) method suitable for simultaneous determination of Ibuprofen and Paracetamol in dissolution of solid dosage forms in pharmaceuticals has been developed. Chromatographic separation was performed on a Waters-Spherisorb C₈ (250 mm × 4.6mm, 5µm) column using a mobile phase of buffer (0.045M phosphoric acid, apparent pH adjusted to 4.0 ±0.2 with triethylamine) and acetonitrile in the ration of 30:70, v/v respectively. The effluent flow rate monitored at 1.0mL/minute, injection volume was 20µL and detected by ultraviolet at 225nm. The retention times of Ibuprofen and Paracetamol 2.7 and 3.8minutes, respectively. The total run time was 6minutes within which the drug product. The developed method has been validated for specificity, precision, linearity, accuracy, ruggedness and robustness. Additionally, the conditions of the dissolution test for Ibuprofen and Paracetamol tablets were presented by using: paddle at 150rpm stirring speed; medium volume of 900mL; temperature at 37±0.5°C; and pH 7.2 phosphate buffer used as dissolution medium. The average percentage drug release was found to be in between 95% to 105% within 30minutes for both drugs. The proposed analytical and dissolution method can be applied successfully for the quality control of commercial Ibuprofen and Paracetamol tablets and the comparison of in vitro dissolution of combination drug products.