Simultaneous Quantification of Acetaminophen, Caffeine, and Ibuprofen in Fixed Dose Combination Drug Using HPLC with UV Detection

Abstract

Combination therapy of analgesics is well suited for pain management especially in elderly patients and, has been recommended by the World Health Organization (WHO). Drug analysis plays an important role in the development, manufacture and therapeutic use of drug. In this study, a suitable, cost effective Isocratic HPLC-UV method (Reversed Phase) has been developed and validated for the simultaneous quantification of Acetaminophen, Caffeine, and Ibuprofen in fixed dose combination drugs, using a mobile phase combination of methanol and 0.025M Phosphate buffer –(adjusted to pH 3.2 with Orthophosphoric acid) in the ratio 85:15.A Vertex Column-Eurospher C18 (250 x 4.6 mm), flow rate of 1.0 ml/min at 25°C were the chromatographic conditions. With Piroxicam as internal standard, quantification was achieved with UV detection at 225 nm based on the peak area responses. A good resolution and a short run time (7mins) were achieved with the validated conditions. In consequence, statistical evaluation at the 95% confidence limits revealed that, the method was Linear; with an average correlation coefficient (R = 0.995), and accurate - (mean recovery 99.45% for Acetaminophen, 100.10% for Caffeine and 99.28% for Ibuprofen). With an instrument and intermediate precision RSDs>2.0, the method was found to be specific, Robust, and more economical. Six formulated combination products on the Ghana market were assayed using the validated method. The Acetaminophen, Caffeine and Ibuprofen contents in the combination drugs varied from 97.35% to 103.88%.