Abstract

Simple, rapid, sensitive, precise and specific UV spectrophotometric for the determination of Teneligliptin Hydrobromide hydrate in bulk drug and pharmaceutical dosage form were developed and validated. In this method solutions of Teneligliptin HBr hydrate were prepared in water. Teneligliptin HBr hydrate standard solution was scanned in the UV range (400-200nm) in a 1cm quartz cell in a double beam UV spectrophotometer. The standard solution of Teneligliptin HBrhydrate showed maximum absorption at wavelength 243.0 nm. The method obeys beers law in the concentration range from10- 50μg/ml. The correlation coefficient was found to be 0.998 and regression of the curve was found y = 0.0223x + 0.01 with excellent recovery 99-104%. Limit of detection and limit of quantitation were found to be 0.556 µg/ml and 14.79µg/ml respectively. The method was validated for several parameters like accuracy, precision as per ICH guidelines. Statistical analysis proved that the methods are repeatable and specific for the estimation of the said drug. These methods can be adopted in routine assay analysis of Teneligliptin HBr Hydrate in bulk or tablet dosage form.

Keywords

Teneligliptin HBr Hydrate, UV Spectrophotometry, Absorbance Maxima, Method validation

Cite This Article

Ghuge, B.S., Pendhari, S.S., Malode, P.A., Anantwar, S.P. (2017). Development and Validation of Simple UV Spectrophotometric Method For The Determination of Teneligliptin Hydrobromide Hydrate In API and its Bulk Dosage Form.  International Journal for Pharmaceutical Research Scholars , 6(2), 44-53.