Mon, 20 Nov 2017

RP-HPLC Method Development and Validation of Metformin and Vildagliptin in Bulk and Its Pharmaceutical Dosage form and their Bio-Analytical Studies

G.Alekya *1, Naira Nayeem1, T.Mahati 1

1. Krupanidhi College of Pharmacy.Bangalore


ABSTRACT

The present work is simple and sensitive RP-HPLC Method Development and Validation for the simultaneous estimation of Metformin and Vildagliptin in bulk and its pharmaceutical dosage form and their Bio-Analytical studies. Chromatography was carried out on Kromosil C18 (4.6 x 250mm, 5mm) column using Phosphate buffer pH 5.8 and Acetonitrile in the ratio of 80:20 as the mobile phase at a flow rate of 1 ml/min with UV detection at 215 nm. The Retention time of Metformin and Vildagliptin is 2.589 mins and 4.296 mins respectively. The detector response is linear. The Limit of Detection for Metformin and Vildagliptin is 0.06 µg/ml and 0.1 µg/ml and Limit of Quantification for Metformin and Vildagliptin is 0.2 µg/ml and 0.4 µg/ml respectively. The Percentage assay for Metformin and Vildagliptin is 99.6% and 99.2% respectively and Percentage Recovery for average of three different concentrations for Metformin and Vildagliptin is 99.9% and 100.1% respectively. The method was validated by determining its selectivity, robustness, linearity, accuracy and precision. The developed method is simple, fast, sensitive, linear, accurate, rugged and precise and hence can be applied for routine quality control of Metformin and Vildagliptin in bulk and its pharmaceutical dosage form.

Keywords: Reverse Phase-High Performance Liquid Chromatography, Metformin, Vildagliptin, Bio-Analysis studies.


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