Mon, 18 Dec 2017

Development and Validation of RP- HPLC Method for the Simultaneous Estimation of Vildagliptin and Metformin In Tablet Dosage Form

Sai Lohit.Ch1 *, Suman Pattanayak1, T. Rama Rao1

1. Department of Pharmaceutical Analysis and Quality Assurance Avanthi Institute of Pharmaceutical Sciences, Guntapally, Hyderabad.


ABSTRACT

A simple, rapid, sensitive, reversed phase-HPLC method was developed and validated to measure simultaneously the amount of Metformin and Vildagliptin at single wavelength (210 nm) in order to assess quantification in its tablet formulation and its subsequent stability studies. An isocratic elution of filtered sample was performed on Hypercil BDS C18 column with buffered mobile phase (0.1 M potassium dihydrogen ortho Phosphate buffer (Ph 4.8) and acetonitrile in the ratio of 60:40 v/v) with Hypercil BDS detection at 210 nm. The linearity for concentrations between 12.5μg/ml–75μg/ml for Metformin and 1.25μg/ml – 7.5μg/ml for Vildagliptin were established.  The limits of detection (LOD) and quantification were 1.75 and 5.29 µg/ml for metformin and 0.46 and 1.39 µg/ml for vildagliptin. The determination of the two active ingredients was not interfered by the excipients of the products. This method was satisfactorily applied to the analysis of the tablet formulations and proved to be specific and accurate for the quality control of the cited drugs in tablet dosage form.

Keywords: RP-HPLC, Metformin, Vildagliptin, 0.1 M potassium dihydrogen ortho Phosphate buffer.


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