Original Articles: 2010 Vol: 2 Issue: 3
Stability indicating RP-HPLC method for simultaneous determination of Terlipressin in pure and pharmaceutical formulation
Abstract
A simple, selective, precise and stability indicati ng High Performance Liquid Chromatographic (HPLC) method of analysis of Terlipressin in pure a nd pharmaceutical dosage form was developed and validated. The chromatographic condit ions comprised of a reversed-phase C 18 column (250 x 4.6 mm), 5 μ with a mobile phase cons isting of a mixture of Acetonitrile- monobasic potassium phosphate solution (35:65v/v) a nd pH adjusted to 3.5. Flow rate was 1.5 mL / min. Detection was carried out at 280 nm. The retention time of Terlipressin was 10.05 min. Terlipressin was subjected to acid and alkali hydro lysis, oxidation, photochemical degradation and thermal degradation. The linear regression anal ysis data for the calibration plots showed good linear relationship in the concentration range 2-12μ g/ml. The value of correlation coefficient, slope and intercept were, 0.9995, 1848 .2and 62.786, respectively. The method was successfully validated in accordance to ICH guideli nes acceptance criteria for specificity, linearity, precision, recovery, ruggedness and robu stness. The drug undergoes degradation under acidic, basic, photochemical and thermal degr adation conditions. All the peaks of degraded product were resolved from the active phar maceutical ingredient with significantly different retention time. As the method could effec tively separate the drug from its degradation product, it can be employed as a stability-indicati ng one.