Journal of International Research in Medical and Pharmaceutical Sciences

To simultaneously quantify the breakdown products of ibuprofen and famotidine in a combination dose form, a stability-indicating reverse-phase ultra-performance liquid chromatographic (RP-UPLC) method was created and verified.  The efficient chromatographic separation was achieved in gradient elution mode containing mobile phase “A” as buffer with 10 mM Sodium Acetate Trihydrate at pH 6.0 ± 0.02 and mobile phase “B” as mixture of buffer and acetonitrile in the ratio of 93:7, v/v on using Waters Acquity UPLC HSS T3 (30 x100 mm, 1.8 μm) column. The UV detection was set at 265 nm and the flow rate was at 0.5 mL/minute. This method was validated to prove the specificity, linearity, limit of detection, limit of quantitation, precision, accuracy, robustness and solutions stability in accordance with ICH guidelines. The Limit of Detection (LOD) was determined to be 0.02% for famotidine and its impurities, and 0.000025% to 0.015% for ibuprofen and its impurities. The Limit of Quantitation (LOQ) was established at 0.05% for famotidine and its impurities, and 0.0125% to 0.05% for ibuprofen and its impurities. The method was linear from 0.05% to 0.5% and 0.05% to 1.0% of the nominal concentration of Ibuprofen, famotidine and its related degradation products respectively. The method demonstrated accuracy over a range of 0.05% to 0.75% of the nominal concentration for famotidine degradation products and 0.05% to 0.25% for ibuprofen degradation products. The developed method was applied for the simultaneous quantitative determination of degradation products of Ibuprofen and Famotidine in the Combination Pharmaceutical Dosage Form and shelf-life stability studies.