Abstract

New chromatographic-densitometric method for determination of clopamide and impurities (4-chlorobenzoic and 4-chloro-3-sulfamoylbenzoic acids) in tablets was developed. Silica gel TLC plates as a stationary phase and nbutanol- 2-propanol -water- methylene chloride (10:7:2:5:3 v/v/v/v/v) as a mobile phase were used for separation. Densitometric measurements were done at λ = 235 nm. Favourable retention parameters (Rf, Rs, k, α) were obtained under developed conditions, which guarantee good separation of studied components. Whereas, results that were obtained from validation method confirm specificity, high sensitivity, linearity in a range of studied concentrations, repeatability and good accuracy of this method.

Keywords: Clopamide, Degradation products, Drug Analysis, Densitometry, TLC