Development and Validation of an RP-HPLC-PDA Method for Determination of Paracetamol, Caffeine and Tramadol Hydrochloride in Pharmaceutical Formulations

Paracetamol (acetaminophen) (PAR), caffeine (CAF) and tramadol hydrochloride (TRA) are important drugs widely used for many clinical purposes. Determination of their contents is of the paramount interest. In this respect, a quick, simple and sensitive isocratic RP-HPLC method with photodiode array detection was developed for the determination of paracetamol, caffeine and tramadol in pharmaceutical formulations. An improved sensitive procedure was also evolved for tramadol using a fluorescence detector system. A C-18 column and a mobile phase constituted by methanol/phosphate were used. LODs were found to be 0.2 mu g/mL, 0.1 mu g/mL and 0.3 mu g/mL for paracetamol, caffeine and tramadol hydrochloride, respectively, using photodiode-array detection. Alternatively, LOD for tramadol decreased to 0.1 mu g/mL with the fluorescence detector. Other notable analytical figures of merit include the linear concentration ranges, 0.8-270 mu g/mL, 0.4-250 mu g/mL and 1.0-300 (0.2-40) mu g/mL, for the same ordered analytes (including the fluorescence detector). The proposed method was successfully applied for the quantitative determination of the three drugs in tablet dosage forms.

Automated summary

A rapid, simple, and sensitive isocratic RP-HPLC method with photodiode array detection was developed for the determination of paracetamol, caffeine, and tramadol in pharmaceutical formulations. An improved procedure for tramadol using a fluorescence detector system was also established.