METHOD DEVELOPMENT AND VALIDATION FOR IMPURITY METHOD OF CINACALCET HYDROCHLORIDE TABLETS (STABLITY INDICATING) BY HPLC TECHNIQUE
Cinacalcet is a calcimimetic agent and acts on calcium sensing receptor of the parathyroid. Also it increases sensitivity of calcium-sensing receptors on parathyroid glands to extracellular calcium, resulting in decreased serum parathyroid hormone (PTH) and calcium concentrations. The chemical name of Cinacalcet Hydrochloride is (R) -N-(3-(3-(trifluoromethyl) phenyl)propyl)-1-(1-naphthyl) ethyl amine Hydrochloride and it molecular weight is 357.4 g/mol and molecular formula, C22H22 F 3N. The calcium sensing receptor on the surface of the chief cell of the parathyroid gland is the principal regulator of parathyroid hormone secretion. It acts by directly lowering parathyroid hormone levels by increasing the sensitivity of the calcium sensing receptors to activation by extracellular calcium, resulting in the inhibition of PTH secretion. The reduction in PTH is associated with a concomitant decrease in serum calcium levels2. Since, the method for determination of Cinacalcet related substances in pharmaceutical products is not described in current pharmacopoeias, the aim of this work was to develop and validate a precise, accurate and robust method. Separation was achieved on a RP C-18 column (50 x 3.0 mm, 2.5 µm particle size) along with pre column, column temperature kept at 40°C. Gradient method developed to achieve the separation. The mobile phase A contains 100% Buffer solution (pH 5.00) and Mobile phase B contains mixture of Acetonitrile and water in the ratio of 95:5 V/V, The preparation of buffer was dissolved in 1.8g of Disodium hydrogen phosphate in 1000 ml of water. pH was adjusted to 5.00 with phosphoric acid. Flow rate of 1.0 ml/min. Injection volume 5µL and UV detection wavelength at 223nm. The method was validated by following ICH guidelines and validation parameters showed that method used as stability indicating for determination of related compound of Cinacalcet hydrochloride tablets