Development and Validation of a Spectrofluorimetric Method for Estimation of Mycophenolate Mofetil in Bulk and in Formulation

   Mycophenolate mofetil is an immunosuppressive agent approved by the Food and Drug Administration. The present report describes the validation of two simple, economical, and highly sensitive spectrofluorimetric methods based on the native fluorescence of the drug in ethanol and in alkaline medium. Fluorescence characteristics of the drug were found to significantly differ in absolute ethanol (λ_ex = 268 nm and λ_em = 426 nm) and in NaOH (λ_ex = 359 nm and λ_em = 434 nm). Both the methods were validated as per the ICH guidelines. Stress degradation studies were conducted on the drug as per the ICH guidelines and excellent recovery from the stressed samples suggested the stability-indicating nature of the methods. The two methods were found to be extremely sensitive, precise, and accurate, demonstrating excellent linearity in the concentration ranges 0.5–15.0 μg/mL (absolute ethanol) and 0.1–8.0 μg/mL (NaOH). The limit of detection and limit of quantitation values were found to be 0.52 and 1.57 µg/mL (absolute ethanol), and 0.02 and 0.07 µg/mL (NaOH), respectively. The proposed methods afforded excellent recovery of mycophenolate mofetil from its marketed tablet formulation, thus suggesting that these methods could be employed for routine analysis of the drug in bulk as well as in formulation.

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