Green validation of synchronous fluorometry study applied on binary mixture (risperidone and biperiden hydrochloride as a co-administered drugs) used for treatment of schizophrenia

Abstract

Risperidone and biperiden hydrochloride concentration levels have been successfully quantified in laboratory prepared mixture, tablets for each studied drug and spiked human plasma through an innovative spectrofluorimetric approach. In order to successfully estimate risperidone at 302 nm and biperiden hydrochloride at 405 nm in the presence of each other at Δλ of 60 nm, the spectrofluorometric technique’s selectivity is increased by combining both derivative and synchronous spectrofluorometric approaches. The technique was extensively validated by following the validation requirements of the International Conference on Harmonization, and linearity was achieved for the two medicines across the range of 20–200 ng mL⁻¹. The technique was successfully used to commercial tablets, combination made in the lab and spiked human plasma. The results showed good agreement with the approaches that have been published. The measurement of risperidone and biperiden hydrochloride in spiked human plasma samples was relevant. The quantitation limits were 11.626 and 11.522 ngmL⁻¹ and the detection limits were 3.873 and 5.023 ng ml⁻¹ for risperidone and biperiden hydrochloride, respectively. A statistical comparison of the results with other published analytical techniques revealed no significant difference. The validation of the procedure was successfully completed in compliance with ICH guidelines. The suggested approach included an environmentally beneficial element by using water as the ideal diluting solvent.