A new validated gas chromatographic method for the simultaneous determination of ibuprofen and paracetamol in bulk and pharmaceutical dosage form

A new gas chromatographic method has been developed for the simultaneous determination of ibuprofen and paracetamol in bulk and pharmaceutical dosage form, using a TRB-5 column (30m in length, 0.25mm-ID and 0.25μm-DF) and nitrogen as a carrier gas at a flow rate of 1ml.min^-1. The oven temperature was programmed at 180°C for 0.5min, with a rise of 15°C up to 250°C. The injector and detector temperature was 300°C. Detection was carried out using Flame Ionization Detector (FID). Methyl paraben was used as an internal standard. The retention times of ibuprofen and paracetamol were (3.681 and 4.089) min respectively. The validation of the method including linearity, range, accuracy, precision, system suitability and robustness was carried out utilizing ICH guidelines. Calibration curves were linear over the range (0.25-1.75)mg/mL for both ibuprofen and paracetamol. The percentage of accuracy for two drugs was found within the acceptance limit of (98–102)%. The precision study results of the new method were less than the maximum allowable limit percentage of relative standard deviation (%RSD) ≤ 2.0%. The proposed method can be easily adopted for the routine analysis of ibuprofen and paracetamol in bulk and pharmaceutical dosage form.