Author(s):
Nitin Kolhe, Priyanka Bhagat, Arvind Naik
Email(s):
nitin.s.kolhe@gmail.com , pb3869407@gmail.com , arvindbnaik@gmail.com
DOI:
10.52711/0974-360X.2026.00521 
Address:
Nitin Kolhe, Priyanka Bhagat, Arvind Naik
LSHGCT's Gahlot Institute of Pharmacy, Plot 59, Sector 14, Koparkhairane, Navi Mumbai, Thane, Maharashtra, State, India.
*Corresponding Author
Published In:
Volume - 19,
Issue - 8,
Year - 2026
ABSTRACT:
According to ICH Q2 (R1) requirements, a simple, reliable, robust, and accurate RP-HPLC method has been developed and validated for the measurement of Belumosudil in dosage form. The separation by chromatography was accomplished using an Inertsustain C18 column (250mm x 4.6mm, 5µm) that was kept at 25°C. The mobile phase comprised a 70:30 (v/v) mixture of acetonitrile and 1 ml orthophosphoric acid per 1000ml water. Belumosudil was detected at 258nm by a UV-visible detector with 0.8ml/min flow and 10µl injection volume. Belumosudil eluted at 8.3min. The method exhibited linearity (R² = 0.9996) over the 50–150µg/ml concentration range. Excellent sensitivity was demonstrated, with the method exhibiting a LOD of 8.98µg/ml and an LOQ of 27.23µg/ml. Accuracy was confirmed through recovery studies, yielding a mean recovery of 100.50%. The mean assay of Rezurock 200mg tablet of Belumosudil, a marketed formulation, was found to be 99.00%. All validation parameters were within ICH limits, confirming the method's suitability for quality control and research applications.
Cite this article:
Nitin Kolhe, Priyanka Bhagat, Arvind Naik. Analytical Method Development and Validation of RP-HPLC Method for Estimation of Belumosudil in Bulk and Pharmaceutical Dosage form. Research Journal of Pharmacy and Technology. 2026;19(8):3691-8. doi: 10.52711/0974-360X.2026.00521
Cite(Electronic):
Nitin Kolhe, Priyanka Bhagat, Arvind Naik. Analytical Method Development and Validation of RP-HPLC Method for Estimation of Belumosudil in Bulk and Pharmaceutical Dosage form. Research Journal of Pharmacy and Technology. 2026;19(8):3691-8. doi: 10.52711/0974-360X.2026.00521 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2026-19-8-38
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