Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF AREA UNDER CURVE APPROACHES FOR TRICLABENDAZOLE ESTIMATION IN BULK AND TABLET DOSAGE FORM

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

Abstract

Triclabendazole in bulk and pharmaceutical dose form can be estimated using a straightforward, accurate, and precise zeroorder derivative UV spectroscopic approach that has been developed and validated. The absorbance of Triclabendazole in methanol reaches its maximum at 306 nm, and the Area under curve in absorption spectra measured between wavelength range in 301nm and 311nm, and its concentration falls between 2 and 12 μg/ml according to Beer's Law. After conducting a linearity investigation, the regression coefficient (R2) was shown to be 0.995, indicating good linearity and precision across this concentration range. The limits of detection (LOD) and quantitation (LOQ) were determined to be 1.55 μg/ml and 4.71 μg/ml respectively, while the percentage recovery was determined to be 99.5%, 99%, and 103.3%. Additionally, the method's relative standard deviation (%RSD) values were less than 2%, indicating exceptional precision. Following ICH criteria, all validation parameters—linearity, accuracy, precision, robustness, ruggedness, LOD, and LOQ—were evaluated. Triclabendazole in bulk and pharmaceutical dosage forms can be routinely estimated using the designed and tested approach.

Keywords: Triclabendazole; Area Under curve; Validation; RP-HPLC; HPTLC, Anthelmintic.