A stability indicating RP-HPLC chromatography method was developed for the estimation of metformin, pioglitazone and glimepiridein tablet dosage form. The separation was achieved on column (4.6 × 250 mm, 5 μm) using acetonitrile and 0.01 % OPA in the ratio of (60:40, v/v) as mobile phase and flow rate 1.0 ml/min. Detection was carried out in U.V detector at 254.0 nm. The retention time 2.300 min for MET, 5.6833 min for PIO and 9.0500 min for GLP respectively. The linearity of the MET, PIO and GLP was found over the range of 100 μg/ml-500 μg/ml, 3 μg/ml-15 μg/ml and 0.2 μg/ml-1.0 μg/ml for MET, PIO and GLP respectively. The method was found to be precise, accurate, robust and rugged as indicated % RSD values less than 2. For developing the force degradation profile the drug product is exposed to degradation medium like acidic, basic, oxidative, neutral, thermal and photolytic. The parent drugs and degradation products formed were well resolved under optimized chromatographic conditions. The % of degradation for metformin was 2.41% (acid), 8.08 % (base), 10.85 % (oxide), 7.67 % (water), 0.42 % (thermal) and 0.21 % (photo) pioglitazone 6.58 % (base), 2.85% (oxide), 4.89 % (water), 2.92% (thermal), 2.01% (photo) while for glimepiride 2.41 % (acid), 3.01 % (oxide), 2.11% (water), 1.91% (thermal) and 0.19% (photo) which is in agreement with ICH limit.
Loading....