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Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF TENELIGLIPTIN BY UV SPECTROSCOPY IN BULK

Dr. Meenakshi Bhatt, *Ms. Sonia Badoni and Dr. Alka N. Choudhary

ABSTRACT

Ultraviolet (UV) spectroscopy is a physical technique of the optical spectroscopy that uses light in the visible, ultraviolet, and near infrared ranges. The Beer-Lambert law states that the absorbance of a solution is directly proportional to the concentration of the absorbing species in the solution and the path length. Thus, for a fixed path length, UV/VIS spectroscopy can be used to determine the concentration of the absorber in a solution. It is necessary to know how rapidly the absorbance changes with concentration. A simple, selective, accurate, precise spectroscopic method for the estimation of teneligliptin hydrobromide in API and tablet dosage form has been developed and validated. The Linearity range of the teneligliptin is 5-55μg/ml and all the parameters shown in table no. 6. The LOD and LOQ were found to be 0.064408μg/ml and 0.0195168μg/ml. The amount of teneligliptin hydrobromide was calculated as 99.3%. The %RSD was found to be 0.2253 it indicated that the method has good precision. All the procedure followed in the present study were as per ICH guidelines. The developed method was simple, cost effective, reproducible and reliable. The maximum absorbance of Teneligliptin was obtained at 240 nm. The method is linear and obeys Beer’s law in the concentration ranges from 5-55μg/ml. The assay value of Teneligliptin was found to be 99.3%.The method was validated for several parameters like accuracy, precision as per ICH guidelines In conclusion, the developed spectrophotometric method is simple, accurate and reproducible and can be used routine analysis of Teneligliptin with 0.1N HCl.

Keywords: Ultra Violet-Spectrophotometry, Teneligliptin, 0.1 Hcl.


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