Estimation of Fexofenadine HCl and Pseudoephedrine HCl by Spectrophotometer and TLC in Combined Tablet Dosage Form

Abstract

The objective of the present work was to develop and validate of an analytical method for the quantitative determination of Fexo. HCL and Pseudo. HCl in a combined tablet dosage form by UV − V is spectrophotometry and TLC. The main problem was to separate the two active ingredient from a single bilayered tablet because both the A.P.I’s were soluble in the same solvents. As media selection, distilled water and ethanol (1 : 1) were used for Pseudo. HCl and methanol for Fexo. HCl, in which both the drugs were soluble and stable for a sufficient time. Both drugs were measured at 220nm and 247nm, where they showed maximum absorbance. Beer Lambert’s law was obeyed at concentration range 4− 14 ppm and 5 − 30 ppm for Fexo. HCl and Pseudo HCl respectively. Fexo. HCl (Y = 0.0643x + 0.9370) was measured with correlation coefficient r = 0.9574 and Pseudo. HCl (Y = 0.0843x+0.0219) with correlation coefficient r = 0.9992. The results of analysis have been validated statistically and recovery studies were carried out as 99.29%±0.943 and 99.29%±0.941 which were close to the assay value 100.1% & 100.6 %. Precision of the method was measured which showed results for SD (99.57 % & 99. 51% ) and % RSD (99.53 % & 99.54). The proposed method may be suitably applied for the analysis of Fexo. HCl and Pseudo.HCl in tablet pharmaceutical formulation for routine analysis.