Quantitaive Analysis of Flubendiamide and its Related Impurities in Bulk Batch by RP-HPLC Method

Author:

Yenduri Gopikrishna1,Navuluri Srinivasu1

Affiliation:

1. Division of Chemistry, Department of Science & Humanities, Vignan’s Foundation for Science, Technology & Research (Deemed to be University), Vadlamudi-522213, India

Abstract

An RP-HPLC method is validated to separate and quantify flubendiamide and its relevant eight related impurities. The ideal chromatographic separation of flubendiamide and its eight allied impurities was performed on Ace-5 C-18 column (5 μm, 25 cm × 4.6 mm) with formic acid (0.1%) in Milli-Q water plus acetonitrile in a gradient elution at a flowing rate of 1.2 mL/min as mobile phase. Photodiode array based detection at wavelength of 240 nm was deployed to monitor flubendiamide and its eight related impurities. The robustness, accuracy, linearity, precision and detection and quantitation limitations of the new RP-HPLC technique for flubendiamide and its eight related impurities were all validated. Both FDE and eight process allied impurities had quantitation limits in the range of 0.07 to 0.12 μg/mL. This new HPLC technique was successfully applied to ascertain the purity of flubendiamide analyte and levels of eight related impurities in five bulk lot products of flubendiamide synthesized in the laboratory. The present study also deals with the bulk batch synthesis of flubendiamide and characterization of flubendiamide and its relevant eight impurities by 1H NMR, ESI-MS and IR spectroscopy.

Publisher

Asian Journal of Chemistry

Subject

General Chemistry

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