Simultaneous Determination and Validation of Flupirtine Maleate and Paracetamol in Combined Dosage Form by Chromatographic Technique

Objective: The focus of this research was to establish a validated high-performance thin layer chromatographic (HPTLC) method for analysing Flupirtine maleate and Paracetamol in a combined dosage form.

Method: Paracetamol and Flupirtine maleate were measured using a mobile phase of Ethyl acetate: Chloroform (7:5 v/v) at 286 nm. This technique was validated in accordance with the International Conference on Harmonization (ICH) guidelines.

Results: The Rf value for paracetamol was 0.31 and 0.52 for Flupirtine maleate in this existing technique. Paracetamol's linearity was found to be in the range of 3250-6500 ng/band, while Flupirtine maleate's linearity was found to be in the range of 1000-2000 ng/band. The method's accuracy was determined by recovery experiments, which revealed a percent recovery of 98 to 102 percent. The % RSD was determined to be less than 2 in the Precision investigation, and the assay result for both compounds was within the limit.