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

[摘要] 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 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.

[学科分类] 化学（综合）

[关键词] Stability-indicating HPLC;paracetamol;caffeine;simultaneous determination;fixed-dose combination tablets;stress degradation study