Volume No. :   9

Issue No. :  3

Year :  2019

ISSN Print :  2231-5667

ISSN Online :  2231-5675


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Development and Validation of Stability Indicating UV Spectrophotometric Method for Estimation of Teneligliptine in Bulk and Tablet Dosage Form



Address:   Parag A. Pathade*, Vinod A. Bairagi, Yogesh S. Ahire, Bhaskar O. Aher
Department of Pharmaceutical Analysis, K.B.H.S.S. Trust’s Institute of Pharmacy, Malegaon- 423105 Dist-Nashik (M.S.) India.
*Corresponding Author
DOI No: 10.5958/2231-5675.2019.00024.3

ABSTRACT:
A simple, sensitive, accurate, precise, reproducible and cost effective stability indicating UV spectrophotometric method has been established for quantitative determination of Teneligliptine in bulk and pharmaceutical formulation. The UV spectrum was scanned between 200 to 400 nm and 243 nm was choosing as maximum wavelength for absorption. Beer’s law has been followed for the drug in the concentration range of 05-25µg/ml. Accuracy was found as (100.10-100.20%), precision as (%RSD 0.995-0.991) however the method was effectively functional to the pharmaceutical dosage form comprising the teneligliptine deprived of any interference through the excipients. According to ICH guidelines these outcomes from analysis has been validated. Forced degradation studies comprises the influence of temperature, oxidation, neutral, photolysis and susceptibility to hydrolysis through a extensive range of pH values, were accepted out approving to the ICH necessities which can be used for the routine and quality control analysis of Teneligliptine bulk as well in pharmaceutical formulations.
KEYWORDS:
Teneligliptine, stability indicating, forced degradation.
Cite:
Parag A. Pathade, Vinod A. Bairagi, Yogesh S. Ahire, Bhaskar O. Aher. Development and Validation of Stability Indicating UV Spectrophotometric Method for Estimation of Teneligliptine in Bulk and Tablet Dosage Form. Asian J. Pharm. Ana. 2019; 9(3):128-132.
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