A STABILITY- INDICATING LIQUID CHROMATOGRAPHIC METHOD FOR THE QUANTIFICATION OF ANTITHYROID DRUG PROPYLTHIOURACIL

A Simple, economic, selective, precise, and stability-indicating high performance liquid chromatography (HPLC) method has been established and validated for the determination of Propylthiouracil in bulk drug. An isocratic, reversed phase HPLC method was developed to separate the drug from the degradation products using an Inertsil ODS 3V C18 (250 x 4.6) mm, 5? column and the mobile phase containing phosphate buffer, orthophosphoric acid and acetonitrile 87:0.1:13 (%, v/v/v), as mobile phase at flow rate 1.0 ml min-1. Detection was performed at 276 nm and a sharp peak was obtained for Propylthiouracil at a retention time of 15.0±1.5 min. The method is validated for its specificity, precision, accuracy, linearity and ruggedness accordance with ICH guidelines. Regression analysis data for the calibration plots were indicative of good linear relationships between response and concentration over the range 100.0?g mL?1 ? 300.0?g mL?1 . The correlation coefficient was 0.9999. The value of slop and intercept of the calibration plot was 60776 and 153148. Statistical analysis proved the method is repeatable, selective and accurate for estimation of Propylthiouracil in bulk drug. Because the method could effectively separate the drug from their possible impurities like ethylbutyrylacetat and thiouea, it can be used as a stability indicating method. The wide linearity range, sensitivity, accuracy, short retention time and simple mobile phase imply the method is suitable for routine quantitation of Propylthiouracil with high precision and accuracy.