Articles Accepted

A NOVEL VALIDATED STABILITY INDICATING ANALYTICAL METHOD FOR QUANTIFICATION OF EMPAGLIFLOZIN IN BULK AND MARKETED FORMULATION BY RP-HPLC APPLYING EXPERIMENTAL DESIGN APPROACH
by Mr. Manojkumar Kisan Munde, 23 Jun 2020

The stability indicating reversed-phase high-performance liquid-chromatography method for analysis of Empagliflozin was optimized by statistical design of experiment, developed and validated as per the ICH guidelines. In optimization process independent variables were used as methanol proportion in mobile phase and flow rate. Experiments were carried out on analytical reversed phase column Cosmosil C18 (250 X 4.6 mm, 5μm). Based on the results obtained from these studies, suitable mobile phase with appropriate composition was selected and utilized for method development using DoE approach. The mobile phase used was methanol: water (85:15 v/v). The flow rate was set at 0.8 mL/min and UV detection was carried out at 225 nm. The retention time for Empagliflozin was found to be 4.259 min. The lower solvent consumption along with the short analytical run time of 10 minute provided a cost effective and environment friendly chromatographic procedure. The measured signal was shown to be precise, accurate and linear over the concentration range tested (10-50 μg/ml) with a correlation coefficient of 0.999. Thus, the proposed methodology is rapid, selective and requires a simple sample preparation procedure and represents a good procedure for analysis of Empagliflozin.

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November 2020
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