Validation of Titrimetric-UV Spectrophotometric Method for the Simultaneous Quantification of Paracetamol, Caffeine and Ibuprofen in Pharmaceutical Dosage Forms

Aim: The objective of this study was to develop a reliable, accurate and precise Titrimetric - UV spectrophotometric method for the assay of fixed dose combination formulations involving Paracetamol, Caffeine and Ibuprofen.

Study Design: Experimental.

Place and Duration of Study: Quality Control Department of SALOM Pharmacy Limited between June, 2015 and January, 2016.

Methodology: The method employed an extraction of Ibuprofen from a fixed dose combination product using petroleum ether (40 – 60°C) and its evaporation followed by titration. The remaining solution was basified with 1 M NaOH and Caffeine extracted with chloroform. The extract was then evaporated and the Caffeine assayed at 273 nm. Finally, the resulting solution was diluted with distilled water and Paracetamol assayed at 257 nm. The developed method was validated as per International Conference on Harmonisation specifications [Q2 (R1)].

Results: Linearity was observed in the concentration range of 3.75 - 9 μg/ml and 4.5 - 10.8 μg/ml for Paracetamol and Caffeine respectively and a titre value range of 4.80 - 11.70 ml for Ibuprofen.

Conclusion: The results demonstrated that the method is accurate, precise, specific, and robust, hence can be suitably applied for simultaneous quantification of Paracetamol, Caffeine and Ibuprofen in laboratory prepared mixtures and in commercial preparation (capsules, caplets and tablets).