Anil Kumar Kota and Mukthinuthalapati Mathrusri Annapurna*
Department of Pharmaceutical Analysis, GITAM School of Pharmacy, Gandhi Institute of Technology and Management, Visakhapatnam, India
*Corresponding Author: Mukthinuthalapati Mathrusri Annapurna, Department of Pharmaceutical Analysis, GITAM School of Pharmacy, Gandhi Institute of Technology and Management, Visakhapatnam, India.
Received: October 21, 2022; Published: November 15, 2022
Tilorone is an anti-viral and immune modulatory drug. It is an inducer of endogenous interferon with low molecular weight. A new RP-UFLC method has been developed and validated for the estimation of Tilorone in bulk and its tablet dosage forms in presence of and internal standard, Eplerenone. Tilorone is used for the treatment of urogenital tract, respiratory infections and viral hepatitis A, B, C. Tilorone stimulates the formation of α, β and γ interferons and produces interferon intestinal epithelial cells, neutrophils, T-lymphocytes and hepatocytes in the body. A mixture of tetra butyl ammonium hydrogen sulphate, acetonitrile and methanol (60: 35:5) was used as mobile phase for the chromatographic study (Isocratic mode) using Agilent C18 column (Detection wavelength 245 nm) with flow rate 0.5 mL/min. Tilorone has shown linearity over the concentration range 0.05-50 µg/mL and the regression equation was y = 0.1075x + 0.0058 with correlation coefficient 0.9999. The LOD and LOQ are found to be 0.0157 and 0.0487 µg/mL respectively. The method was validated as per ICH guidelines. The proposed RP-UFLC method was found to be precise, accurate, and robust for the quantification of Tilorone in tablet dosage forms.
Keywords: Tilorone; RP-UFLC; Eplerenone; Internal Standard; Acetonitrile; ICH Guidelines
Citation: Anil Kumar Kota and Mukthinuthalapati Mathrusri Annapurna. “Development and Validation of a New RP-UFLC Method for the Quantification of Tilorone in Presence of Internal Standard". Acta Scientific Pharmaceutical Sciences 6.12 (2022): 25-31.
Copyright: © 2022 Anil Kumar Kota and Mukthinuthalapati Mathrusri Annapurna. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.