Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ZERO-ORDER APPROACHES FOR TRICLABENDAZOLE ESTIMATION IN BULK AND TABLET DOSAGE FORM

Dr. Sowmya H. G., Karthik M. L.*, Dr. Naveen Kumar G. S.

Abstract

A simple, accurate, and precise zero order derivative UV spectroscopic method has been devised and validated for the estimation of triclabendazole in bulk and tablet dosage form. According to Beer's law, the concentration of triclabendazole in methanol ranges from 2 to 12 μg/ml, and its absorbance reaches its maximum at 306 nm. The area under the curve in absorption spectra is measured between 301 and 311 nm. The regression coefficient (r2) was found to be 0.995 following a linearity investigation, demonstrating acceptable linearity and precision over this concentration range. The percentage recovery was found to be 99.5%, 99%, and 103.3%, while the limits of detection (LOD) and quantitation (LOQ) were found to be 1.55 and 4.71 micrograms per milliliter, respectively. Furthermore, excellent precision was indicated by the methodologies' relative standard deviation (% RSD) values, which were less than 2%. All validation metrics, including linearity, accuracy, precision, ruggedness, LOD, and LOQ, were assessed in accordance with ICH requirements. The developed and proven method can be used to regularly estimate the dosage of triclabendazole in both bulk and tablet form.

Keywords: Triclabendazole; Quantification; Validation; RP-HPLC; HPTLC, Anthelmintic.