A novel spectrofluorimetric method for the assay of pseudoephedrine hydrochloride in pharmaceutical formulations via derivatization with 4-chloro-7-nitrobenzofurazan

Luminescence. 2011 Nov-Dec;26(6):510-7. doi: 10.1002/bio.1261. Epub 2010 Nov 8.

Abstract

A new highly sensitive and specific spectrofluorimetric method has been developed to determine a sympathomimetic drug pseudoephedrine hydrochloride. The present method was based on derivatization with 4-chloro-7-nitrobenzofurazan in phosphate buffer at pH 7.8 to produce a highly fluorescent product which was measured at 532 nm (excitation at 475 nm). Under the optimized conditions a linear relationship and good correlation was found between the fluorescence intensity and pseudoephedrine hydrochloride concentration in the range of 0.5-5 µg mL(-1). The proposed method was successfully applied to the assay of pseudoephedrine hydrochloride in commercial pharmaceutical formulations with good accuracy and precision and without interferences from common additives. Statistical comparison of the results with a well-established method showed excellent agreement and proved that there was no significant difference in the accuracy and precision. The stoichiometry of the reaction was determined and the reaction pathway was postulated.

Publication types

  • Validation Study

MeSH terms

  • 4-Chloro-7-nitrobenzofurazan / chemistry*
  • Pharmaceutical Preparations / chemistry*
  • Pseudoephedrine / analysis*
  • Reference Standards
  • Spectrometry, Fluorescence / methods*

Substances

  • Pharmaceutical Preparations
  • Pseudoephedrine
  • 4-Chloro-7-nitrobenzofurazan