A novel reversed-phase liquid chromatographic method was developed for the quantitative determination of fingolimod and its related impurities. The chromatographic separation was achieved on a RP18 150 x 4.6 mm, 5 µ column and gradient program with mobile phase A as a pH 3.0 phosphate buffer and acetonitrile as mobile phase B. Fingolimod were monitored at 220 nm. Fingolimod was subjected to the stress conditions of acid, base, oxidative, thermal and photolytic degradation and found to degrade significantly under oxidative stress conditions. The degradation products were well separated from the main peak and its impurities, proving the stability indicating the power of the method. The method was validated according to the ICH guidelines for specificity, linearity, accuracy, precision, limit of detection, limit of quantification, ruggedness and robustness.
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