A novel analytical method development and validation for the estimation of flupirtine maleate in bulk and tablet dosage form by RP-HPLC

A simple, precise, and fast isocratic RP-HPLC method was developed for the RP-HPLC quantification of flupirtine maleate in tablet and bulk dose forms by examining several parameters, the analytical approach was created. Excellent peak purity and maximum absorbance were observed at 347 nm. A satisfactory peak area was obtained by choosing an injection volume of 20μl. Phenomenex C18 was the column used for the study, and it had a decent peak shape. Given the nature of the medication solution, it was determined that ambient temperature was appropriate. A good peak area and a sufficient retention duration led to the flow rate being set at 1.0 ml/min. A good symmetrical peak allowed for the fixation of the 2.5% formic acid:methanol ratio in 60:40. Because the analysis showed a peak at 3.449 and to cut down on the overall run time, the run time of 7 minutes was chosen.It was discovered that the current recovery was linear over the same range, ranging from 99.2% to 101%. It was determined that the precision of the system and the procedure were both accurate and well within range. It was discovered that the detection limit was 1.4. Findings from the linearity investigation included the correlation coefficient and curve fitting. Over the 20–80 ppm range of the target concentration, the analytical approach was shown to be linear. Both the robustness and ruggedness tests were passed by the analytical. The relative standard deviation was good in both circumstances.