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

Autor: Nafiu Aminu, Muhammad Nura Umar, Nasir Hayat Khan, Ahmed Farhan, Siok-Yee Chan, Seok-Ming Toh
Rok vydání: 2019
Předmět:
Zdroj: Acta Chromatographica. 31:85-91
ISSN: 2083-5736
Popis: 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® 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 (tR) was found to be 2.6 ± 0.001 and 3.5 ± 0.002 min for PCM and CF, respectively. Extensive stress degradation s...
Databáze: OpenAIRE