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Journal of Pharmaceutical and Medicinal Chemistry

Volume  5, Issue 1, January-June 2019, Pages 41-46

 

Original Article

RP-HPLC Method Development and Validation for Estimation of Dalfampridine in Pure and Tablet Dosage Form
T. Prasanthi1, A. Lakshmana Rao2, Shabana Begum3, S. Tejaswini4, T. Krishna5, TNSD Prathima6
1Associate Professor, 2Professor & Principal, 3-6Students, Department of Pharmaceutical Analysis, V.V. Institute of Pharmaceutical Sciences, Gudlavalleru, Krishna, Andhra Pradesh 521356, India.
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DOI: http://dx.doi.org/10.21088/jpmc.2395.6615.5119.5

Abstract

A simple, economic, rapid, accurate and stability indicating RP-HPLC method was developed for the estimation of amount of of Dalfampridine in pure and tablet dosage form. The method was performed on Phenomenex C18 (125 X 4.6 mm, 5 µm) using the mobile phase composed of buffer (0.01M sodium acetate pH 4.5): methanol in the ratio of 60:40 v/v. Th flow rate was maintained at 0.8 mL/min. The retention time for Dalfampridine was found to be 1.713 min. The method was found to be linear in the range of 5-25 µg/mL and the regression equation was found to be y=14691x-12844. For intra- and inter-day precision the %RSD for Dalfampridine was found to be 0.218 and 0.622%. Percentage mean recovery was found to be 98.36%. LOD and LOQ values obtained for Dalfampridine were found to be 0.107 µg/mL and 0.323 µg/mL respectively. Acid, alkali, oxidative, thermal and neutral degradation studies were performed. The results are analysed statistically and are found to be satisfactory. Hence this method can be routinely applicable for analysis of Dalfampridine in pure and tablet dosage form. Keywords: Dalfampridine, RP-HPLC, Recovery, Dosage form.


Corresponding Author : T. Prasanthi