A simple, specific, accurate and stability-indicating high performance liquid chromatographic method was developed\r\nand validated for the determination of Epinastine Hydrochloride in pharmaceutical dosage form. The chromatographic\r\nconditions comprised of a reverse-phase, C18 column (150Ã?â??4.6 mm), 5Ã?µm with a mobile phase consisting of a mixture of\r\naqueous phase (3.8g of sodium pantanesulphonate monohydrate and 4.0g of potassium dihydrogen orthophosphate\r\nwas dissolved in 1L of water and pH of solution was adjusted to 4.5 with o-phosphoric acid) and organic phase\r\n(acetonitrile and methanol was mixed in the ratio of 4:1 v/v) in the ratio of 60:40 v/v at a flow rate of 1.0ml/min.\r\nDetection was carried out at 220nm. The retention time of Epinastine Hydrochloride was found to be 3.5 min. The\r\ncalibration curve was found linear between 2-200Ã?µg/ml. The percentage recoveries of Epinastine Hydrochloride were\r\nfound to be in the range of 99.05-100.50%. The method was validated for accuracy, linearity, precision, detection limit,\r\nquantitation limit and robustness. The drug was subjected to acidic hydrolysis, basic hydrolysis, neutral hydrolysis,\r\noxidation, photochemical and thermal degradation. All the peaks of degraded product were resolved from the active\r\npharmaceutical ingredient with significantly different retention time. As the method could effectively separate the drug\r\nfrom its degradation product, it can be employed as a stability indicating one.
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