Development and validation of stability indicating RP-HPLC method for simultaneous estimation of empagliflozine and linagliptin in tablet formulation

Abstract

A stability indicating high Performance Liquid Chromatographic (HPLC) method was developed and validated for the estimation of combined tablet formulation of Empagliflozine and Linagliptin. Chromatographic separation was optimized by isocratic HPLC on a C18 column [BDS 250mm x 4.6 mm, 5μ.] utilizing a mobile phase consisting a mixture of 0.1% Perchloric acid and Acetonitrile in the ratio of 60:40 v/v at a flow rate of 1ml/min with UV detection at 230nm. The retention time of Empagliflozine and Linagliptin was 2.05 min and 4.10 min respectively. Good linearity obtained over the range of 12.5μg/ml to 75μg/ml for Empagliflozine and Linagliptin. Correlation coefficient was found to be 0.999&0.999 for Empagliflozine& Linagliptin respectively. The % RSD of precision for Empagliflozine and Linagliptin was found to be 0.33and 0.22respectively. The % mean recovery was found to be 100.96-101.48% for Empagliflozine and 100.09-101.13% for Linagliptin. The results obtained for accuracy, precision, LOD, LOQ and Ruggedness were within the limits. Thus the validated economical method was applied for forced degradation study of Empagliflozine and Linagliptin tablet.

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Cite this paper

@inproceedings{Naazneen2016DevelopmentAV, title={Development and validation of stability indicating RP-HPLC method for simultaneous estimation of empagliflozine and linagliptin in tablet formulation}, author={S. Naazneen and A S Sridevi}, year={2016} }