Simultaneous determination of carbinoxamine maleate and pseudoephedrine HCl in their pure form and in their pharmaceutical formulation by HPTLC-densitometric method

Abstract

An accurate, sensitive and selective High Performance Thin Layer Chromatography (HPTLC) method has been developed and validated for determination of carbinoxamine maleate and pseudoephedrine HCl in their binary mixture without previous separation. Chromatographic separation was performed on aluminum plates precoated with silica gel 60F₂₅₄ using acetone: methanol:ethylacetate:triethylamine (5:4:2:0.2, v:v:v:v) as a developing system. The bands were scanned at 215 nm. The proposed method has been validated as per ICH guidelines and its linearity was evident in the ranges of 0.4-8.0 and 4-24 µg/ band for carbinoxamine maleate and pseudoephedrine HCl, respectively. The developed method has been applied for determination of the above mentioned drugs in their pharmaceutical formulation where no interference from methyl paraben present as excipient has been detected. Statistical comparison of the results obtained by the developed HPTLC method and those obtained by the reported HPLC method showed no significant difference between them. The developed method is sensitive, accurate and precise and can be easily used for quality control analysis of the studied drugs.