MUMBAI, India, Aug. 17 -- Intellectual Property India has published a patent application (202641096139 A) filed by Pushadapu Veera Venkata Siva Krishna; Vignan Pharmacy College; P. Jitendra Kumar; P. Srinivasa Babu; Y. Indira Muzib; Garima Kapoor; G. Raghavendra Kumar; and Sk. Abdul Rahaman on August 08, 2026, for Stability-Indicating Rp-Hplc Method For Quantitative Determination Of Voclosporin In Bulk And Pharmaceutical Dosage Forms.
Inventors include Pushadapu Veera Venkata Siva Krishna; P. Jitendra Kumar; P. Srinivasa Babu; Y. Indira Muzib; Garima Kapoor; G. Raghavendra Kumar; and Sk. Abdul Rahaman.
The application for the patent was published on August 14, 2026, under issue no. 33/2026.
Abstract: The present invention relates to a stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for the quantitative determination of Voclosporin in bulk drug and pharmaceutical dosage forms. The method provides a rapid, sensitive, specific, precise, accurate, robust, and reproducible approach for routine quality control and stability assessment of Voclosporin. The chromatographic separation is achieved using an Agilent C18 column (4.6 × 250 mm, 5 µm) with 0.01 N potassium dihydrogen phosphate buffer and acetonitrile in a ratio of 70:30 as the mobile phase, at a flow rate of 1.0 mL/min, column temperature of 30°C, injection volume of 10 µL, and detection wavelength of 220 nm. Under the optimized conditions, Voclosporin exhibits a retention time of approximately 2.446 minutes with a total run time of 5 minutes. The method demonstrates excellent system suitability, precision, linearity, accuracy, sensitivity, and robustness, with a correlation coefficient of 0.999, mean recovery of 99.93%, assay of 99.38%, limit of detection (LOD) of 0.15 µg/mL, and limit of quantification (LOQ) of 0.47 µg/mL. Forced degradation studies under acidic, alkaline, oxidative, thermal, photolytic, and aqueous conditions demonstrate the suitability of the method for stability-indicating analysis. The developed method enables reliable separation and quantitative estimation of Voclosporin and its degradation-related changes and is suitable for routine pharmaceutical quality control and stability testing.
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