Abstract

STABILITY INDICATING ASSAY METHOD FOR SIMULTANEOUS ESTIMATION OF MELATONIN AND PYRIDOXINE HYDROCHLORIDE IN PHARMACEUTICAL FORMULATION.

Parth Shah, Payal Chauhan, Jinal Tandel, Samir Shah

ABSTRACT

A simple stability indicating high-performance liquid chromatographic method was developed and validated for simultaneous estimation of Melatonin and Pyridoxine Hydrochloride in bulk and combined pharmaceutical dosage form. Reversed-phase chromatography was performed on Solvent Delivery system, Model S-1122. The separation was achieved by ODS hypersil C18, with an isocratic system of 0.2M KH2PO4 buffer (pH – 4.5): methanol in the ratio of (45:55v/v) as a mobile phase with a flow rate of 1.0 ml/min having Injection volume 20μl, Detection wavelength was selected 251nm. The retention time for Melatonin and Pyridoxine Hydrochloride was found to be 3.51 min and 5.24 min respectively. The linearity of developed method was achieved in the range of 3.0-9.0μg/ml for Melatonin and 10.0-30.0 μg/ml for Pyridoxine Hydrochloride. Correlation coefficient was 0.9994 and 0.9995 for Melatonin and Pyridoxine respectively. The Melatonin and Pyridoxine Hydrochloride were subjected to stress conditions including Acidic, Alkaline, Oxidation, Thermal and Sunlight degradation. The method was validated as per ICH guidelines.

Keywords: RP-HPLC, Validation, Stability indicating method, Melatonin (MELA), Pyridoxine (PYRI).