Author(s):
Jayesh D. Patil, Amitkumar R. Dhankani, Sunil P. Pawar
Email(s):
patiljayesh314@gamil.com
DOI:
10.52711/2231-5675.2024.00026 
Address:
Jayesh D. Patil, Amitkumar R. Dhankani, Sunil P. Pawar
Department of Quality Assurance, Poojya Sane Guruji Vidya Prasarak Mandal, Shahada, Dist. Nandurbar, 425409, (MS), India.
*Corresponding Author
Published In:
Volume - 14,
Issue - 3,
Year - 2024
ABSTRACT:
Two new, simple, specific, precise and accurate UV-spectrophotometric and one reverse phase high performance liquid chromatography methods have been developed for the estimation of Diroximel Fumarate in Pharmaceutical dosage form. First UV-spectrophotometric methods show absorption maxima at 253nm for the Diroximel Fumarate. Percentage mean recovery obtained was 100.00%; coefficient of variance was found to be less than 2% and linearity coefficient was 0.9998. Linear response obtained for Diroximel Fumarate was in the concentration range of 0.5-2.5?g/ml. The limit of detection and limit of quantification for Diroximel was found to be 0.049?g/ml and 0.149?g/ml, respectively, and Second RP-HPLC method, chromatography analysis is carried out using Methanol: 10mm of KH2PO4 buffer solution (pH 3.1) (70:30%, v/v) as the mobile phase and C18 Waters (4.6mm x 150mm), 5.0µ column as stationery phase with detection wavelength of 272nm linearity was obtained in the concentration range of 5-25µg/ml for Diroximel Fumarate. Both UV-spectrophotometric and reverse phase high performance liquid chromatography methods were statistically validated according to I.C.H. Guidelines.
Cite this article:
Jayesh D. Patil, Amitkumar R. Dhankani, Sunil P. Pawar. Development and Validation of RP-HPLC and UV Spectroscopy Method for the Determination of Diroximel Fumarate in Bulk Drug and Pharmaceutical Dosage Form. Asian Journal of Pharmaceutical Analysis. 2024; 14(3):147-0. doi: 10.52711/2231-5675.2024.00026
Cite(Electronic):
Jayesh D. Patil, Amitkumar R. Dhankani, Sunil P. Pawar. Development and Validation of RP-HPLC and UV Spectroscopy Method for the Determination of Diroximel Fumarate in Bulk Drug and Pharmaceutical Dosage Form. Asian Journal of Pharmaceutical Analysis. 2024; 14(3):147-0. doi: 10.52711/2231-5675.2024.00026 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2024-14-3-7
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