Abstract
Objective: The objective is to develop a novel, rapid, simple, precise, accurate, and reproducible RP-HPLC method for simultaneous estimation of paracetamol, caffeine, and propyphenazone in bulk and a pharmaceutical dosage form. Method: Optimized chromatographic conditions were used for isocratic elution with Shimadzu C18 (4.6×250 mm, 5 μm), methanol, and 20mM phosphate buffer (60:40, v/v, pH 2.5) as mobile phase, flow rate 1.2 mL/min, and UV detector at λ max 272 nm. The method was validated for specificity, precision, linearity, accuracy, robustness, and solution stability as per the International Council for Harmonization (ICH) guidelines. Result: It was discovered that the retention time for paracetamol, caffeine, and propyphenazone was found to be 2.6 min, 3.0 min, and 7.5 min. The method proved to be rapid, simple, linear (R2>0.999), precise {relative standard deviation (RSD<2.0%)}, accurate (recovery 98–102%), sensitive, and robust. Conclusion: The proposed novel isocratic RP-HPLC method was found to be rapid (short run time of 10 min), highly selective, accurate, and sensitive. The method has been successfully applied to the simultaneous analysis of paracetamol, caffeine, and propyphenazone in a pharmaceutical formulation.
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