alexa A Stability-Indicating LC Method for Lumefantrine
Biomedical Sciences

Biomedical Sciences

International Journal of Biomedical Data Mining

Author(s): Kiran R Patil, Vipul P Rane, Jaiprakash N Sangshetti, Devanand B Shinde

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A simple, rapid, and precise method is developed for the quantitative determination of lumefantrine (Lume) in active pharmaceutical ingredient (API). A chromatographic separation of Lume and its degradants were achieved with an X-Terra RP18, 250 × 4.6 mm, and 5 μ analytical column using buffer–acetonitrile (30:70 v/v). The buffer used in mobile phase contains 0.1 M sodium perchlorate monohydrate in double distilled water pH adjusted to 2.1 with trifluoroacetic acid. The instrumental settings are flow rate of 0.5 mL (L), column temperature at 35 °C, and detector wavelength of 235 nm using a photodiode array detector. Lume was exposed to thermal, photolytic, hydrolytic and oxidative stress conditions, and the stressed samples were analysed by the proposed method. Peak homogeneity data of Lume obtained by photodiode array detection, in the stressed sample chromatograms, demonstrated the specificity of the method for estimation in the presence of degradants. The described method shows excellent linearity over a range of 10–200 μg L−1 for Lume. The correlation coefficient is 1. The relative standard deviation of peak area for six measurements is always less than 2% between days. The proposed method was found to be suitable and accurate for quantitative determination and stability study of Lume in API.

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This article was published in Chromatographia and referenced in International Journal of Biomedical Data Mining

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