A simple stability-indicating HPLC method for simultaneous analysis of paracetamol and caffeine and its application to determinations in fixed-dose combination tablet dosage form

Abstract

A simple, economic, rapid, reliable, and stability-indicating high-performance liquid chromatography (HPLC) method has been developed and validated for the simultaneous determination of paracetamol (PCM) and caffeine (CF) in solid dosage form. The chromatographic separations were achieved with a Waters Symmetry W C18 column (5 μm, 4.6 × 150 mm), using a mixture of methanol and water (40:60, v/v) as a mobile phase, under isocratic elution mode with a flow rate of 0.8 mL/min, and ultraviolet (UV) detection was set at 264 nm. The oven temperature for the column was set and maintained at 35 °C. The method was validated according to International Conference on Harmonization (ICH) guidelines, and it demonstrated excellent linearity, with a correlation coefficient of 1 and 0.9999 for PCM and CF, respectively, over the concentration ranges of 15-300 μg/mL (PCM) and 2.5-50 μg/mL (CF). The retention time (t R ) was found to be 2.6 ± 0.001 and 3.5 ± 0.002 min for PCM and CF, respectively. Extensive stress degradation studies were conducted by subjecting the analytes to various stress conditions of acidic and alkaline hydrolysis as well as oxidative, photolytic, and heat degradations. The method was found to efficiently separate the analytes' peaks from that of the degradation products, without any variation in their retention times. The relative standard deviation (RSD) values of all recoveries for PCM and CF were less than 1.3%. The method was found to be suitable for routine analysis of PCM and CF in pharmaceutical dosage form.

Potential and Comparative Tablet Disintegrant Properties of Pectin Obtained from Five Okra Genotypes in Ghana

“…(2) Assay . The content of paracetamol in each of the eighteen batches was determined using a reverse-phase chromatographic technique developed and validated in [ 28 ] with some modifications. Twenty paracetamol tablets were randomly sampled and weighed accurately and the average weight was recorded.…”

“…e physicomechanical properties of formulated tablets such as weight, dimensions, friability, crushing strength, and disintegration times were assessed using Pharmacopoeia methods [22,26,27] (2) Assay. e content of paracetamol in each of the eighteen batches was determined using a reverse-phase chromatographic technique developed and validated in [28] with some modifications. Twenty paracetamol tablets were randomly sampled and weighed accurately and the average weight was recorded.…”

High-Performance Liquid Chromatography for Determining a Mixture of Nonsteroidal Anti-inflammatory Drugs

“…To reduce the gastrointestinal side effects, NASIDs are frequently treated as a mixture form with proton pump inhibitors such as omeprazole, esomeprazole, and pantoprazole [7][8][9]. In addition, for the enhancement of the drug potency, NSAIDs have been treated with caffeine as a fixed-dose combination [10,11]. Therefore, there are growing researches on the simultaneous analysis of the mixture forms regarding NSAIDs [1][2][3][4][5][6].…”

Isocratic Reverse-Phase HPLC Method for Determination of Aspirin, Paracetamol, and Naproxen

“…As the use of multi-component drugs increases in medicine, there is a need for a quantitative method to analyze the components in a drug mixture accurately [1][2][3][4][5]. Chromatography, a method that separates a mixture of ingredients based on their molecular structure and composition, has been widely used for protein purification and antibody separation [6,7].…”

“…The chemical structures are shown in Figure 1. Tablets with a fixed-dose combination of NSAIDs with caffeine are more effective than the individual NSAIDs [2,3]. Also, NSAID mixtures with gastric ulcer reducers, such as omeprazole, esomeprazole, and pantoprazole acting as proton pump inhibitors, are broadly used to reduce the gastric side effect of NSAIDs [1,4,5].…”