VALIDATED RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF IBUPROFEN AND PSEUDOEPHEDRINE IN PHARMACEUTICAL FORMULATION

An accurate, precise and reproducible reverse-phase HPLC method has been developed and validated for the simultaneous estimation of Ibuprofen and Pseudoephedrine in combined dosage form. Separation was achieved using Eclipse Phenyl 3.5μ, column (150×3.0mm) and Methanol: 0.05% Triethylamine Buffer (4:96) pH adjusted to 7.0 with o-phosphoric acid as mobile phase which shows sharp and resolved peak at a flow rate 0.7 mL/min and UV detection at 210 nm. The linearity of the proposed method was evaluated for the concentration range of 12-240 μg/mL(r = 0.9999) for Ibuprofen, 7.2-145 μg/mL(r = 0.9999) for Pseudoephedrine. The retention time for IBU and PSD were found to be 8.26 and 4.999 respectively. The mean % estimation and recovery of the drugs was found near to 100 % representing the accuracy of the method. Validation of the proposed method was carried out for its accuracy, precision, specificity and ruggedness according to ICH guidelines. The proposed method can be successfully applied in routine work for the determination of Ibuprofen and Pseudoephedrine in combined dosage form.