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

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

An HPLC method with UV detection to understand degradation path way of epirubicin and it’s quantification in injection as pharmaceuticals formhas been developed and validated as per guidelines fromICH. It is to be employed for routine and stability analysis of epirubicin.Alinear isocratic elutionwas employed startingwith 44%A, 18%B and 36%C up to 30 min.Mobile phaseAwas 1.5g/mLof sodiumlauryl silicates add 1.0mLof ortho phosphoric acid and adjust pH-3.6 with sodium hydroxide. B and C were methanol and acetonitrile respectively. UV detection was performed at 254 nm.The chromatographic columnwas InertsilODS-3 (150mmX4.6mm) 5.0µ kept at 25°C. All impurities were separated and it was possible to quantify the epirubicin in formulation with precision and accuracy. The method was validated for determination of epirubicin over linearity range from 67.20µg/mL to 100.80µg/mL with limit of detectionwas 0.12µg/mL.

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