Development of stability indicating HPLC method for the assay of irinotecan in the presence of degradents

Author(s): A.K.Srivastava, K.Pallavi, S.Shamshul, S.C.Khurana

A LC method with UV detection to understand degradation path and quantification of irinotecan in injection as pharmaceuticals form has been developed and validated as per guidelines from ICH, USP and other regulatory agencies. It is to be employed in routine and stability analysis.Alinear isocratic elution was employed starting with 72%Aand 28%B up to 30 min.Mobile phaseAwas 0.005MHeptance sulphonic acid and 0.05MDibasic phosphate buffer of pH 3.0. Mobile phase B was acetonitrile. UV detection was performed at 254 nm. The chromatographic columnwasHypersilC18,Hyper bond (300mmX3.9mm) 10.0µ kept at room temperature. All impurities were separated and it was possible to quantify the irinotecan in formulation with reasonable accuracy and precision. The method was validated for its specificity, precision, accuracy, linearity, ruggedness and robustness. Correlation coefficient for irinotecan peak area was found to be 1.000 for linearity ranging between 32.49 µg/mL to 48.74 µg/mL and limit of detectionwas 0.50 µg/mL.

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