Online ISSN: 2515-8260

Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Empagliflozin and Linagliptin in Solid Dosage Forms

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Udai Bhan Singh Rathore1 , Dr. Pradeep Kumar Goyal2

Abstract

Abstract This study describes the development of an innovative, rapid, precise, selective and sensitive reverse phase high-performance liquid chromatography method for the quantitative determination of Empagliflozin (EMPA) and Linagliptin (LINA) in bulk and pharmaceutical dosage form as per International Conference on Harmonization (ICH) guidelines. In the present work, good chromatographic separation was achieved by isocratic method using a Thermo C18 column (250 mm ×4.6, 5μm) and a mobile phase consisting of acetonitrile: methanol in the ratio 50:50% v/v, at a flow rate of 1 ml/min. The effluents obtained were monitored at 280nm with the UV-visible detector. The calibration curves obtained were linear (r2=0.999) over the concentration range of 5-25μg/ml and 1-5μg/ml for EMPA and LINA respectively. The retention time of EMPA and LINA was found to be 3.357± 0.3min and 4.085± 0.3min respectively. A run time of 7.0 minutes for each sample made it possible to analyze more than 200 samples per day. The limits of detection were 0.10 and 0.12μg/ml for LINA and EMPA respectively, and the limits of quantification were 0.25 and 0.40μg/ml for LINA and EMPA respectively. The high recovery values (99%-101%) indicate a satisfactory accuracy. The low percent relative standard deviation (% RSD) values in the precision study reveal that the method is precise therefore the method can be used for routine monitoring of EMPA and LINA in industry in the assay of bulk drug and dosage form.

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