DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR THE DOFETILIDE Authors: Patel TR , PATEL RM, SINHA A AND PATEL KB
ABSTRACT
A simple, rapid, accurate and economic HPTLC method has been developed for estimation of
Dofetilide. In HPTLC method, chromatographic separation was carried out on TLC plate,
precoated with silica gel 60F 248 using mobile phase Chloroform: Methanol: Ammonia
(7:3:0.5) and scanning at 248 nm. HPTLC methods showed satisfactory linearity with
correlation coefficient greater than 0.99 and linearity was demonstrated from 500-3000
ng/band for DOFE. The methods successfully developed and validate the Dofetilide in their
dosage form. All method validation parameters for HPTLC lie within its acceptance criteria
as per ICH Q2(R1) guidelines. Hence, the proposed methods can be used for Dofetilide in
quality control analysis.
Keywords: Dofetilide, Validation, HPTLC, Quantitative determination, Methanol Publication date: 01/12/2023 https://ijbpas.com/pdf/2023/December/MS_IJBPAS_2023_7593.pdfDownload PDFhttps://doi.org/10.31032/IJBPAS/2023/12.12.7593
