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Validated Isocratic/Gradient RP-HPLC for Simultaneous Estimation of Paracetamol Ibuprofen and Caffeine in Marketed Formulations Using Diclofenac as Internal Standard

Palled PJ, Dushyanth Reddy V, Mannor VS and Bharat Chowdary

Objective: To develop a validated RP-HPLC method for simultaneous estimation of Paracetamol Ibuprofen and Caffeine. Methods: The HPLC instrument used was Shimadzu LC-20AD with reverse phase ODS-Hypersil-C18 (250 mm × 4.6 mm, 5 μm) column using Acetonitrile:water (90:10) pH adjusted to 2.8 as mobile phase. The flow rate was maintained at 0.3 ml/min and UV detection was carried at 203 nm.

Results: The method was validated for linearity, accuracy, precision, specificity, robustness and ruggedness according to ICH guidelines. The retention time for Paracetamol, Ibuprofen and Caffeine was found to be 9.7, 12.66 and 10.48 respectively. The regression analysis showed good linearity over the concentration range of 1.25 μg/ml to 20 μg/ml for paracetamol, 0.625 μg/ml to 10 μg/ml for Ibuprofen and 0.625 μg/ml to 10 μg/ml for Caffeine. The recovery studies of the method gave good results in the range of 99.89% to 100.48% with less than 2% of RSD.

Conclusion: The method was found to be suitable for the analysis of marketed formulation in presence of other excipients.