The Development and Validation of a Thin Layer Chromatography Densitometry Method for the Analysis of Diclofenac Sodium Tablets

Abstract

A Thin Layer Chromatog. (TLC) method for the qual. and quant. anal. of diclofenac sodium tablets was developed and validated according to ICH and USP guidelines. The method was developed using a mobile phase prepd. with environment-friendly solvents: toluene, acetone and glacial acetic acid (10:15:0.2 vol./vol./v), on pre-coated TLC silica gel 60 F254 glass plates with a satn. time of 25 min and a densitometer detection wavelength of 284 nm in the reflectance absorbance mode. The Rf of diclofenac sodium was at 0.60 and the method was repeatable, robust with good selectivity and specificity. Regression functions were established over the range of 250-600 ng/spot with r2 of 0.993 and 0.999 for the linear and polynomial regressions resp. The accuracy at nominal concn. was found to be 100.2%, and the results of the assay of 3 brands for diclofenac sodium tablets were found to meet the USP 95 to 105 % assay limits thus demonstrating the usefulness of the method for the assay of these products. The developed assay method for diclofenac sodium in tablets is simple, accurate, and inexpensive, with good precision and should be esp. useful in resource constrained countries. [on SciFinder(R)]