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Dr. Dhrubo Jyoti Sen
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Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC AND UV DERIVATIVE SPECTROPHOTOMETRIC METHODS FOR THE DETERMINATION OF METFORMIN HCL AND PIOGLITAZONE IN PHARMACEUTICAL FORMULATIONS

Dr. Usharani N.*, Keerthana K., Sarika M., Revathi D., Kusuma D., Kumari V.Y.

Abstract

A UV derivative spectrophotometric method and high-performance liquid chromatographic method for the simultaneous determination of metformin (MET) and pioglitazone (PIO) in tablets were developed in the present work. First and second order derivatization was carried out in Agilent Cary 60 UV/Vis double beam spectrophotometer. The first and second order derivative spectra obtained for Metformin and Pioglitazone were at 210 nm, 226 nm and 230 nm, 240 nm respectively. HPLC method was carried out by using Agilent 1220 Infinity LC equipped with Eclipse XDB plus C18 Column (4.6 × 150 mm, 5μm) with a mobile phase consisting of Methanol and Tetrahydrofuran in the ratio of 70:30%v/v at a flow rate of 1ml/min. The drugs were monitored at 230 nm. The retention time of Metformin HCl and Pioglitazone were found to be 1.02 and 2.51min respectively. The proposed methods were validated as per ICH guidelines in terms of accuracy, precision, linearity, LOD and LOQ. The proposed methods were found to be suitable for simultaneous determination of Metformin HCl and Pioglitazone in bulk and in pharmaceutical dosage forms.

Keywords: UV derivative spectroscopy, RP-HPLC, Metformin HCl, Pioglitazone, Validation, Optimization, Zero crossing point.


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