Green spectrofluorimetric assay of dantrolene sodium via reduction method: application to content uniformity testing

Abstract

Green analysis has turned out to be of a great value in all areas, including pharmaceutical analysis. Thus, it is extremely important to consider the environmental influence of each step in developing any analysis technique. The present work illustrates a validated, simple and green spectrofluorimetric method for the analysis of dantrolene sodium (DAN). The developed process is characterized by being of high sensitivity as well as being relatively inexpensive. The suggested technique based on the formation of a highly fluorescent product of DAN via its reduction by the aid of Zn/HCl system. The resulting fluorophore showed a powerful fluorescence at λem 344 nm after excitation at λex 279 nm. Calibration graph revealed a great linear regression (r = 0.9998) within concentration ranging from 0.05 to 2.0 µg ml−1. The suggested method had very low detection and quantification limits of 0.010 and 0.031 µg ml−1, respectively. The applied technique was effectively used in the determination of DAN in its pharmaceutical preparations. The results were compared with those from using the official United States Pharmacopeia (USP) method and they were in a good agreement. Moreover, content uniformity testing of DAN in capsules was performed adopting the investigated technique with satisfying results. The greenness of the suggested technique was confirmed by the three standard assessment tools. Therefore, the developed technique can be used in the routine quality control analysis of DAN with minimum harmful impact on nature or individuals.

Keywords

• green analysis
• dantrolene sodium
• reduction
• spectrofluorimetry
• pharmaceutical formulations
• content uniformity testing