Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences and Computational Chemistry

Abstract

Application of RP-HPLC and UV-Spectrophotometric Method in Dissolution Testing of Teneligliptin

Author(s): Atul T Hemke, Yogesh G Ghuge, Krishna R Gupta

Characterization of drug product performance in the pharmaceutical field has become very essential; Dissolution testing has emerged as an important tool. Teneligliptin is mainly used for the treatment of type-II diabetes mellitus, not official in any of the monographs. The objective of the study was to develop and validate UV spectrophotometric and RP-HPLC methods for dissolution testing for the quality control of Teneligliptin tablets. In vitro dissolution tests of tablets were performed using different trial conditions. The satisfactory sink conditions (Test conditions) includes phosphate buffer of pH 7.5 (900 ml at 37 ± 0.5°C) as dissolution medium, USP Apparatus II (paddle method) with agitation speed of 50 rpm. The method was found to be linear with correlation coefficient (r2=0.999) in the concentration range of 10-60 μg/ml. The chromatographic separation was achieved on Shodex C18 column with isocratic mode using a mixture of methanol: phosphate buffer (pH 7.2) in the ratio of 70:30 v/v, flow rate of 1 ml/min and detection wavelength was 245.6 nm. The recovery of the drug at three levels was found to be nearly equal to 100%. The proposed dissolution test method is adequate and can be applied for the quality control of 20 mg Teneligliptin tablets.


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