The present study describes the development and subsequent validation of a stability indicating RP-HPLC method for the estimation of Isoniazid in tablet dosage form. Numerous HPLC conditions were tested for the estimation of Isoniazid. The best result was achieved by using Inertsil ODS 3V (150mm X 4.6mm, 5µ) column, and mobile phase comprising of ammonium acetate adjusted to the pH 5.5 with glacial acetic acid and methanol (90:10) in isocratic mode at a flow rate of 2ml/min at 350C temperature with ultraviolet detection at 240nm. The linear response was observed in the range of 15-90 µg/ml with a correlation coefficient of 0.9995. Accuracy (98.9-99.9%) and precision were found to satisfactorily within limits. The proposed method has adequate specificity for the estimation of Isoniazid in tablet dosage form. The method was proved to be robust with respect to changes in flow rate, column temperature and wavelength. Isoniazid was subjected to stress degradation under different stress conditions like alkali, acid, peroxide and thermal. The simple, sensitive, precise, rapid and specific method was developed and validated statistically for the estimation of Isoniazid in tablet dosage form.
Loading....