STABILITY INDICATING UV SPECTROSCOPIC METHOD FOR THE ESTIMATION OF METFORMIN HYDROCHLORIDE IN BULK AND TABLETSAbstract
Background: Forced degradation studies are used to determine the degradation pathways and degradation products of the active pharmaceutical ingredients that could form during storage and facilitate formulation development, manufacturing and packaging. Aim: To develop and validate simple and precise stability indicating UV Spectrophotometric method for Metformin Hydrochloride in the bulk and tablet dosage form. Material and Method: Separation of the drug from its degradation products was achieved by UV Spectrophotometric method using distilled water and scanned between 200 to 400 nm. Metformin Hydrochloride was subjected to stress conditions such as hydrolysis (acid and base), oxidation, photolysis, and thermal degradation. The degraded samples were further analyzed by using this method. Results: The maximum absorbance was found to be at 232.2nm and found to be linear over the range 2-10µg/ml with good correlation coefficient (r2) 0.998. The limits of detection and quantification were 0.5232 and 1.5856µg/ml, respectively. Major degradation was observed in acid hydrolysis, photolysis, and oxidative conditions. Metformin Hydrochloride was quite stable under the other stress conditions investigated. Conclusion: The UV Spectrophotometric method for Metformin Hydrochloride in the bulk and tablet dosage form was developed and validated. Thus, the method is proved to be stability indicating and was found to be an economical, selective, and sensitive for the desirable range.
V. P. Patil *, S. S. Angadi, S. H. Kale, S. D. Shelke, S. T. Kawade and R. L. Kadam
Department of Pharmaceutical Analysis, Yash Institute of Pharmacy, Aurangabad, Maharashtra, India.
23 July 2014
28 October 2014
04 December 2014
01 January 2015