TLC-DENSITOMETRIC DETERMINATION OF TOLPERISONE AND ITS IMPURITIES 4-METHYLPROPIOPHENONE AND PIPERIDINE IN PHARMACEUTICAL PREPARATIONS

Abstract

A chromatographic-densitometric method was developed for determination of tolperisone hydrochloride and its impurities. Silica gel TLC_{F 254} plates were used as the stationery phase and cyclohexane-1,4 dioxane-isopropanol–ethanol-glacial acetic acid (16:0.5:1:4:0.6 v/v/v) and n-butanol-isopropanol-water-glacial acetic acid (10:7:8:2 v/v/v/v) as the mobile phases. Densitometric measurements were done at 260 nm for tolperisone hydrochloride and 4-methylpropiophenone and at 570 nm for piperidine hydrochloride. The method is specific, sensitive, precise, and has a broad range of linearity, with potential application in pharmaceutical analysis.

Keywords:

• 4-methylpropiophenone
• densitometry
• impurities determination
• piperidine
• TLC
• tolperisone

Notes

P, peak surface area; m, mass [µg per band]; a, slope of regression line; b, y-intercept, RSD, relative standard deviation; x_sr, mean.

S_d, standard deviation; RSD, relative standard deviation.

S_d, standard deviation; RSD, relative standard deviation.