UV Spectrophotometric Method Development and Validation for Determination of Teneligliptin Hydrobromide Hydrate in API and in Pharmaceutical Dosage Form

Author(s)

Kshirsagar, S.A., Mane, S.B., Hanchate, Y.S., Katte, A.S., Kulkarni, K.V.

Author's Affiliation

Abstract

Simple, rapid, sensitive, precise and specific UV Spectrophotometric for the determination of Teneligliptin Hydrobromide Hydrate (THH) in API and pharmaceutical dosage form were developed and validated. In this method solutions of Teneligliptin Hydrobromide Hydrate (THH) were prepared in Dimethyl Sulphoxide (DMSO). Teneligliptin Hydrobromide Hydrate (THH) 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 THH showed maximum absorption at wavelength 267.2 nm. The method obeys Beer’s law in the concentration range from 20-100µg/ml. The correlation coefficient was found to be 0.999 and regression of the curve was found Y=0.012x+0.058 with excellent recovery 102-104%. Limit of detection and limit of quantification were found to be 4.1987µg/ml and 12.7233µg/ml respectively. The ruggedness and robustness were performed. 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 determination of the said drug. These methods can be adopted in the routine assay analysis of Teneligliptin Hydrobromide Hydrate (THH) in API and pharmaceutical dosage form.

Keywords

Teneligliptin Hydrobromide Hydrate (THH) UV Spectrophotometry, Absorbance maxima, Method validation

Cite This Article

Kshirsagar, S. A., Mane, S. B., Hanchate, Y. S., Katte, A. S., & Kulkarni, K. V. (2018), UV Spectrophotometric Method Development and Validation for Determination of Teneligliptin Hydrobromide Hydrate in API and in Pharmaceutical Dosage Form, International Journal for Pharmaceutical Research Scholars , 7(1), 19-27.