Development and Validation of Novel Ultra Performance Liquid Chromatography Technique for the Simultaneous Determination of Metformin and Repaglinide in Bulk and Formulation
H. K. Sundeep Kumar *
Institute of Pharmacy and Technology, Salipur, Cuttack, Odisha, 754202, India.
Suman Acharyya
Netaji Subhas Chandra Bose Institute of Pharmacy, Chakdaha, Nadia, West Bengal, 741222, India.
Pratap Kumar Patra
Sree Duttha Institute of Pharmacy, Sheriguda, Ibrahimpatnam, Hyderabad, Telangana. 501510, India.
*Author to whom correspondence should be addressed.
Abstract
A novel ultra-performance liquid chromatographic technique for the estimation of metformin and repaglinide in a API and tablet dosage form. The chromatographic separation was achieved using DIKMA Endoversil (2.1 x 50mm, 1.7µm) column with a mobile phase of phosphate buffer, pH 4.2 and methanol as a mobile phase (38:62) with a flow rate of 0.3 mL/min and the detection wavelength was monitored at 241 nm. The method was validated in accordance with International conference on harmonization guidelines. In this present method metformin was eleued at 0.516 minute and repaglinide was eluted at 1.152 min. Limit of detection was 0.05 μg/ml for metformin and1.152 μg/ml for repaglinide limit of quantification was found 0.5 μg/mL. Calibration curve plots were found linear over the concentration ranges 1-50 μg/mL for both the analytes. The % assay of the marketed dosage form was found 99.45 % for metformin and 97.08 % for repaglinide. The present study approach was found to be effective in the analysis of both analytes in force degradation conditions, because both the analytes has been specifically eluted in presence of other chromatograms. The experiential evidences of all the study results revealed the suitability of the estimation of metformin and repaglinide in API and tablet dosage form.
Keywords: Metformin, repaglinide, UPLC, method development, ICH Guidelines