DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR ESTIMATION OF LEFLUNOMIDE IN ITS PHARMACEUTICAL DOSAGE FORM
Journal Title: International Journal of Drug Regulatory Affairs - Year 2017, Vol 5, Issue 4
Abstract
A specific, accurate, precise and robust HPTLC method has been developed for estimation of Leflunomide in its pharmaceutical dosage form. The chromatographic separation was performed using Aluminum backed precoated with silica gel 60F254 as stationary phase and toluene: ethyl acetate: glacial acetic acid (8:2:0.5 %, v/v/v) as mobile phase. The quantification was carried out at 270 nm wavelength. The method was validated as per ICH Q2 (R1) guidelines. The Rf value was found to be 0.53 ± 0.02. The linearity of method was satisfactory over the range 25-125 ng/spot with correlation coefficient of 0.9960.The limit of detection was found to be 1.71 ng. The limit of quantitation was found to be 5.19 ng. The recovery was found in the range 99.67-100.89%.The method was successfully applied to marketed formulations of Leflunomide. Keywords
Authors and Affiliations
Sola Kavita A, Dedhiya Praful P, Shah Shailesh A
Keywords
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- EP ID EP329132
- DOI 10.22270/ijdra.v5i4.210
- Views 114
- Downloads 0
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