Abstract
An easy, specific, and reliable method for determining voclosporin has been established using the reversed phase-high performance liquid chromatography (RP-HPLC) approach. Chromatographic conditions included stationary phase C18 Kromasil (250 mm x 4.6 mm and 5 μm), solvent system (0.1% OPA: Acetonitrile) in a 60:40 ratio, 1-mL/min flow rate, and detection wavelength of 282 nm were opted to separate the voclosporin with retention time of 2.2 minutes. A linearity analysis was performed between 3.95 to 23.7 μg/mL, and the R2 value was found to be 0.999. Precision’s %RSD was determined to be between 0.4 and 0.7. The limit of detection (LoD) and limit of quantitation (LoQ) values are 0.01 and 0.03 μg/mL, respectively. Using the aforesaid approach, the %assay of the marketed formulation was 99.07%. To test the stability representing characteristics of the suggested approach, forced degradation experiments of voclosporin were performed and %degradation was measured. Because the procedure was easy, precise, accurate, and cost-effective, it may be poted for regular analysis of quality control samples in industry
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