Abstract

DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF METHYLPREDNISOLONE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Vijaya Krishna C. Aradhya, *Greeshma S. E., A. Satish Kumar Shetty, Anil kumar

ABSTRACT

A simple, precise, stability indicating RP-HPLC method was developed and validated for the assay determination of methylprednisolone in bulk drug and dosage form. LC separation was achieved isocratic mode on a Inertsil C18 (25cm x 4.6 mm), 5 μm column using mobile phase containing phosphate buffer (pH8) :acetonitrile in the ratio 50: 50 at flow rate 1ml/min. The detection wavelength was 240 nm. The retention time was 4.8min and linearity was observed in the concentration range of 10-50 μg/ml with correlation coefficient of 0.999. The percentage relative standard deviation in accuracy and precision studies was found to be less than 2%. The method was successfully validated as per ICH guidelines. Degradation impurities did not interfere with the retention time of Methylprednisolone, and assay method is thus stability indicating.

Keywords: Methylprednisolone, validation, HPLC, Stability indicating.