A new rapid stability-indicating reversed phase ultra-performance liquid chromatographic (RP-UPLC) method with a linear gradient and shortest run time of 4.0 minutes is developed for the determination of assay of pemetrexed disodium, an anti-cancer drug from its lyophilized parenteral formulation. The method is developed on Waters UPLC system, using Aquity BEH C18 column with mobile phase containing gradient mixture of solvent A and B and the eluted compounds were monitored at 230 nm. Pemetrexed was subjected to the stress conditions like oxidative, acid, base, hydrolytic, thermal, and photolytic degradation, within which major degradants were observed in acid stress at 1N HCl 60°C and 3% peroxide stress at room temperature. Evaluation of spectral purity for main component was performed using PDA (photo diode array) in presence of its forced degradation products formed in stress conditions, which assures the stability indicating capability of the method. % RSD for mean of precision and accuracy at 3 different levels ranging from 50 to 150% were within limits and coefficient of correlation found > 0.999 for linearity. The developed method is fully validated as per ICH guidelines with respect to specificity, linearity, Accuracy, precision and robustness.
Key words: Pemetrexed, UPLC, Aquity BEH C18, Forced degradation, Peak purity, Photo diode array (PDA), Method validation.
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