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

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2016-11-07
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Acetylsalicylic acid and paracetamol belong to a class of drugs called analgesics and are often formulated together in combination with Caffeine, an adjuvant for the relief of pain, fever and inflammations. A RP-HPLC method has been developed and validated for the simultaneous estimation of acetylsalicylic acid, paracetamol and caffeine in multi-component drug formulation. The developed method made use of a Brownlee Analytical column C8, 5 µm, 150 x 4.6 mm as the stationary phase and acidic water-methanol mixture (60:40 v / v ) ratio as the mobile phase. All the three components were eluted within 5.5 minutes with mean 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 validated based on validation parameters such as accuracy, linearity, precision, robustness, specificity, limit of detection (LOD) and limit of quantification (LOQ). The mean recoveries were 99.39 ± 1.58 %, 99.69 ± 1.45 % and 100.56 ± 1.60 % for acetylsalicylic acid, paracetamol and caffeine respectively. Linearity of the developed method was in the concentration range of 20-100 ppm with R 2 value of 0.9933 for acetylsalicylic acid, 2.5-20 ppm with R 2 value of 0.9978 for paracetamol and 1.25-10 ppm with R 2 value of 0.9991 for caffeine. The % RSD for inter and intra- days precisions were 0.408; 0.143, 0.056; 0.091, and 0.470; 0.207 for acetylsalicylic acid, paracetamol and caffeine respectively. The LOD and LOQ for acetylsalicylic acid, paracetamol and caffeine were 1.078x10 -5 ; 3.267x10 -5 , 0.00; 0.00 and 1.237x10 -7 ; 2.193x10 -6 ppm respectively. Accurate results obtained for the assay of both tablet samples (A and B) also confirmed the validity of the developed method. The developed method is therefore, accurate, linear, precise, specific, robust, sensitive and cost effective and can be used in routine quality control analysis of multi-component drug formulations containing these three active ingredients
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A thesis submitted to the Department of Chemistry, Faculty of Physical Science, College of Science, Kwame Nkrumah University of Science and Technology in partial fulfilment for the requirements for the degree of Master of Philosophy in Analytical Chemistry, 2015
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