Stability-Indicating RP-HPLC Method for Simultaneous Quantification of Paracetamol and Flupirtine Maleat

The simultaneous quantification of paracetamol (PAR) and flupirtine maleate (FLU) was accomplished with a precise and accurate stability-indicating reversed phase high performance liquid chromatographic method. This method used an ACE C18 (250 × 4.6mm, 5µ) column and a mobile phase made of methanol: phosphate buffer, pH 7.5 (40: 60, v/v), pumped at a flow rate of 1.0mL min-1. Quantification was accomplished using photodiode array (PDA) detection at 250nm. It was discovered that the retention periods for PAR and FLU were, respectively, 3.09 and 4.54 minutes. For PAR and FLU, linearity was confirmed in the range of 32.5 - 95.7µg mL-1 and 10 - 30µg mL-1, respectively. Both medications underwent oxidation, neutral hydrolysis, acid-alkali, and dry heat degradation; the stressed samples. At their Rt values, the degraded peaks showed a considerable divergence from the analyte peak that could be well resolved. Method validation followed ICH norms. It was discovered that the planned and verified stability-indicating HPLC approach was straightforward, sensitive, and repeatable for the measurement of the medications under study and the byproducts of their degradation in bulk and commercial goods.