#161 A validated stability-indicating UPLC method development and forced degradation study for simultaneous quantification of ibuprofen and caffeine in capsule dosage form

Abstract

A rapid and stability-indicating Ultra-Performance Liquid Chromatography (UPLC) method was developed for simultaneous quantification of Ibuprofen and Caffeine in their combined dosage form, especially to get some more advantages over other methods already developed for this combination using Photo Diode Array (PDA) detector. The separation was achieved on a UHP ASB C18 column (2.1 mm X 50 mm, 1.9 µm) at a wavelength of 254 nm, using a mobile phase A: Mobile B (Methanol: Buffer) (70:30 v/v) in an isocratic elution mode at a flow rate of 0.1 mL/min. The retention time for Ibuprofen and Caffeine was found to be 6.5 min and 1.9 min, respectively. The percentage RSD of the Ibuprofen and Caffeine were and found to be 0.6 and 0.5, respectively, and the percentage recovery was obtained at 100.3% and 100.6%. The method showed excellent linear response with correlation coefficient (R²) values of 0.999 for both drugs. Intra-and inter-day precision studies of the new method were less than the maximum allowable limit percentage of relative standard deviation (% RSD) ≤ 2.0. The drug was subjected to acidic, alkaline media, boiling, heat, humidity, and oxidizing agent to apply stress conditions. The developed method did not show any interference of degrading peaks generated under forced degradation studies. The developed method was found to be simple, accurate, precise, and cost-effective. The forced degradation studies indicated that the degradants and excipients are within the limit. Hence, the developed method was suitable for quantitative analysis of Ibuprofen and Caffeine both in bulk and combined pharmaceutical dosage form. The study suggests that the developed UPLC method can be used for the assessment of drug purity and stability.