Development and Validation of a RP-HPLC Method with PDA Detection for the Simultaneous Estimation of Acetylsalicylic Acid, Paracetamol and Caffeine in Fixed Dose Combination Tablets

Acetylsalicylic acid and paracetamol are often formulated together in combination with caffeine, an adjuvant, for the relief of pain, fever and inflammations. A new RP-HPLC method with PDA detection has been developed and validated for the simultaneous estimation of acetylsalicylic acid, paracetamol and caffeine in fixed dose combination tablets. A Brownlee analytical column RP-C8 (5 μm, 150 x 4.6 mm) was used as the stationary phase and a mobile phase composed of acidic water/methanol mixture (60/40 v /v). Isocratic elution was employed. All the three components were eluted within 5.5 minutes with retention times of 2.05 ± 0.0062 for Paracetamol, 2.45 ± 0.0030 for Caffeine, and 5.03 ± 0.0140 for acetylsalicylic acid. The method was found to be accurate with mean recoveries of 99.39 ± 1.58 %, 99.69 ± 1.45 % and 100.56 ± 1.60 % for acetylsalicylic acid, paracetamol and caffeine respectively. It was also found to be linear (R 2 ˃ 0.99), precise (RSD ˂ 2.0), specific, robust, sensitive and cost effective. Two brands of tablets containing the three active ingredients were successfully assayed by the validated method. The validated method can be used in routine quality control analysis of fixed dose combination tablets containing these three active ingredients.