Establishment and Validation of a Stability-Indicating RP-HPLC Method for Quantitative Determination of Voclosporin in Bulk and Pharmaceutical Dosage Forms

Abstract

A sensitive, specific, and precise RP-HPLC method was developed for estimating voclosporin in its capsule dosage form. Chromatographic separation was carried out using an Agilent C18 column (250 x 4.0 mm, 5 µm). The mobile phase consisted of 0.01N phosphate buffer and acetonitrile in a 70:30 ratio, with a flow rate of 1 mL/min. The column temperature was set at 30°C, and the detection wavelength was optimized at 220.0 nm. The retention time for voclosporin was 2.446 minutes. The % relative standard deviation (RSD) for voclosporin was 0.1%, and the repeatability precision % RSD was 0.7%. The recovery of voclosporin was 99.93%, and the assay result was 99.38%. The limits of detection (LOD) and quantification (LOQ) were 0.15 µg/mL and 0.47 µg/mL, respectively, based on the regression equation. The regression equation was determined to be y = 13283x + 2123. This method offers reduced retention and run times, making it efficient, economical, and suitable for routine quality control testing in pharmaceutical industries.