Analytical Method Validation of Eperisone Hydrochloride in Tablet Dosage form by TLC–Densitometry

Abstract

Context: Eperisone HCl is a muscle relaxant and vasodilator that is related to how the drug works on the central nervous system and vascular smooth muscle, works on peripheral centers and has analgesic action. One method of analyzing single substances from Eperisone HCl is Thin Layer Chromatography (TLC)–Densitometry. Aims: The purpose of this research to determinate the Eperisone hydrochloride level in tablet dosage form. Methods and Material: Using Thin Layer Chromatographic (TLC)– densitometry method with methanol as solvents, methanol p.a: ammonium p.a (100:1) as the mobile phase, pre–coated TLC Silica Gel 60 F254 plate as the stationary phase and followed by densitometric measurements of their spots at 267 nm. Statistical analysis used: The parameters that used for the interpretation of analytical method validation results are the calculation of retention factor (Rf) value, correlation coefficient (r), relative standard deviation (RSD), and % recovery. Results: This method shows good selectivity/specificity with Rf value 0.6 ± 0.02. The linearity signal using 10 standard concentrations of 50 mg L −1 to 500 mg L −1 gives a good linear relationship with r = 0.994 04. Limit of detection and limit of quantitation are (40.545, 121.637) mg L −1 respectively. Precision are tested for three different days and it’s found that the RSD value is 0.8 %. Accuracy with the results of the % recovery value in various additions is 99.3 % ± 0.9 %. Conclusions: This method was found to be fast, specific, precise and accurate also can be successfully applied for the analysis of Eperisone HCl in marketed dosage forms.