Spectrophotometric method for quantitative determination of triclabendazole in bulk and pharmaceutical

Abstract

Background: Triclabendazole (TCBZ, 6-chloro-5(2-3 dichlorophenoxy)-2-methyl thio-benzimidazole), an halogenated benzimidazole (BZD) thiol derivative, shows high efficacy against both the immature and mature stages of Fasciola hepatica in sheep and cattle, which is a differential feature compared to other available trematodicidal drugs. As a consequence of its excellent activity against the liver fluke, it has been extensively used and this has inevitably promoted the selection of TCBZ-resistant populations, which is now a worrying problem in several areas of the world. We propose simple ultraviolet spectrophotometric method for the estimation of triclabendazole in 0.1 methanolic HCl for the estimation of the drug. Method was validated as per ICH guidelines. Materials and Methods: Spectral absorbance measurements were made on Shimadzu UV-1800 with 10 mm matched quartz cells and dilutions were made in 0.1 M methanolic HCl. Results: The LOD and LOQ of triclabendazole at 305 nm were found to be 0.068434 and 2.73×10-4 µg/ml respectively. The calibration was linear in the range of 1-10 µg/ml. Analytical parameters such as stability, selectivity, accuracy, and precision have been established for the method in Endex and Fasinex tablets and evaluated statistically to assess the application of the method. Conclusion: Method passes all parameters with in desirable limits and found to be simple, stable, sensitive, reproducible, and accurate for the routine analysis of the drug in pharmaceutical formulations and in pharmaceutical investigations involving triclabendazole.

Application of liquid chromatographic method with fluorescence detection for the determination of triclabendazole in tablets and biological fluids

“…). The results obtained by the proposed method were in good agreement with that obtained using the comparison method . The high percentage recoveries and the small values of the relative standard deviations and percentage relative errors indicate the high accuracy and precision of the proposed method, respectively.…”

“…To prove the accuracy of the proposed method, the results of the assay of the studied drug were compared with those obtained using the comparison method . Statistical analysis of the results obtained using Student's t ‐test and the variance ratio F ‐test revealed no significant difference between the performance of the two methods regarding the accuracy and precision, respectively (Table ).…”

“…The comparison method was a spectrophotometric technique based on the absorption spectrum of TCB at 305 nm in 0.1 m methanolic HCL. The proposed procedure offers additional advantages over the comparison method in that it offered a much higher sensitivity (down to 50 ng/mL) compared to it (down only to 1 µg/mL), in addition to the application of the proposed method to the determination of TCB in spiked human plasma.…”

“…Triclabendazole (TCB) (6‐chloro‐5‐(2‐3 dichlorophenoxy)‐2‐methyl thio‐benzimidazole) is a halogenated benzimidazole thiol derivative . It has a high efficacy against both the mature and immature stages of Fasciola hepatica in sheep and cattle, which is a differential feature compared to other available trematodicidal drugs .…”

“…A literature survey revealed many methods for the analysis of TCB, none of them was an high‐performance liquid chromatography (HPLC) method with fluorescence detection. These methods include spectrophotometric methods , HPLC methods with ultraviolet detection , and mass spectrometry . This paper presents a simple, sensitive and accurate method for the determination of TCB in pure and in laboratory prepared tablets, and in biological fluids.…”