A VALIDATED STABILITY INDICATING RP-HPLC METHOD OF ESTIMATION OF ROSIGLITAZONE IN DOSAGE FORM
Pramila T.*, Alka Agarwal and Maya Sharma
A simple, specific, precise, and accurate RP-HPLC method has been developed and validated for the estimation of Rosiglitazone maleate in bulk and tablet dosage form. Chromatographic separation was achieved on Hypersil BDS, C8 250 x 4.6 mm, 5 column using 0.01M potassium phosphate buffer and acetonitrile PH(4.0) (30:70v/v) as mobile phase, methanol as diluent in isocratic mode. Flow rate of 1.0ml/min was optimized with detection wavelength at 230 nm. The retention time (Rt) was around 4.72±0.2 min. The method was validated with respect to specificity, selectivity, linearity, accuracy, precision, and robustness as per ICH guidelines. The assay method was observed linear in the concentration range of 0.079-0.318 mg/ml with a Correlation coefficient (r2) 0.9999. The percentage recovery of active pharmaceutical ingredient from tablet dosage form ranged from 99.40-100.40%. Stress conditions of degradation in acidic, alkaline, peroxide, thermal and UV radiation were studied.
Keywords: Rosiglitazone, HPLC, validation, Forced Degradation studies.
[Full Text Article]