Area Under Curve Method Development And Validation Of Fenspiride Hydrocholride In Pharmaceutical Dosage Form

Abstract

Quick, inexpensive, accurate, precise, and repeatable, the suggested method may be used for routine quality control examination of this medication in pharmaceutical dose forms.  The approach is ideal for determining the presence of Fenspiride HCl in pharmaceuticals because the analytical techniques were precise, exact, and specific. Six injections of a solution containing analyte at 100% of test concentration will be used as part of system suitability testing to ascertain the accuracy and precision of the system. Plate count, tailing factors, resolution, and repeatability (percent RSD of retention time, peak area, and height for six injections) are the parameters that will be determined. The AUC findings show the instrumental response for the calibration curve's reference standard. Fenspiride HCl was found to be linear over the concentration range of 5–25 μg /ml. According to ICH criteria, the developed methods were validated in terms of linearity, accuracy, precision, and sensitivity. Validation was then used to demonstrate the applicability of these methods for quantitative chemical determination.