STABILITY INDICATING RP-HPLC METHOD FOR THE DEVELOPMENT AND VALIDATION OF VOCLOSPORIN IN BLUK AND PHARMACEUTICAL DOSAGE FORMS

Abstract

For the purpose of estimating voclosporin using the RP-HPLC methodology in both bulk and pharmaceutical dose form, a straightforward, precise, and uncomplicated approach was established. The Agilent 150 stationary phase with dimensions of 4.8 μm × 5 μm is utilised in the chromatographic process. An optimised approach was used to finalise the following parameters: a detection wave length of 218 nm, a column temperature of 26 oC, a mobile phase consisting of 0.5% formic acid in water:acetonitrile (80:20) and a flow rate of 1.2 ml/min. The results showed that the retention duration of voclosporin was 2.153 minutes. The relative standard deviation (RSD) for the Voclosporin was determined to be 0.8%, and for the method precision, it was determined to be 0.7%.The percentage of recovery for voclosporin was 100.46%. The regression equation for Voclosporin is y = 22385x + 1431.2, and the LOD and LOQ values that were determined from it were 0.04, and 0.12, respectively. The new approach was easy and affordable, allowing it to be implemented for routine quality control tests in industries. It lowered retention times and run time.