DEVELOPMENT AND VALIDATION OF RP- HPLC METHOD FOR THE DETERMINATION OF METHOTREXATE IN BULK AND PHARMACEUTICAL TABLET DOSAGE FORM
Madhumita Roy*, Mukesh Mohite and Sandesh Shah
A new RP-HPLC method was developed and validated for determination of Methotrexate in bulk and tablet dosage
form. The estimation was carried out on Enable C18 (250 mm ×4.6 mm, 5 μm) column using Distilled water:
Acetonitrile in the ratio of 80:20 (v/v) at pH 3 with Formic acid as mobile phase. The flow rate was 1.0 ml/min and
the effluent was monitored by UV detector at 211 nm. The retention time was 3.28 min and linearity was observed
in the concentration range of 8-60μg/ml. The percentage recovery was in good agreement with the labelled amount
in the pharmaceutical formulations and the method was simple, precise and accurate for the determination of
Methotrexate in bulk and pharmaceutical formulations.
Keywords: Methotrexate, HPLC, Validation.
[Full Text Article]