Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF METFORMIN HCL IN FLOATING TABLET DOSAGE FORM BY RP-HPLC

Anshuman Keshari*, Dr. Pushpendra Kumar Tripathi, Indu Singh, Richa Shukla

ABSTRACT

A Simple, sensitive and rapid reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of Metformin HCl in Floating tablet dosage form. The chromatographic determination was performed on isocratic High performance liquid chromatography system of Agilent model no.1260. Hypersil BDS C18 (150 x 4.6-mm), 5-μm column was used with a mobile phase containing a mixture 6.8 gm potassium dihydrogen phosphate, (K2H2PO4) and 0.5 gm of 1- Octane Sulphonic acid sodium solt in 1000 ml of mili- Q water and Acetonitrile and in the ratio of 70:30. The flow rate was 1.0ml/min and effluents were monitored at 255nm and eluted at Run time 10 min respectively. Calibration curve was plotted with a range from 55-832 ppm. The assay was validated for the parameters like System Suitability, Specificity, Linearity, Precision, (a) System Precision (b) Method Precision / Repeatability, Accuracy Range, Robustness, (a) Flow Rate (± 0.1 mL) (b) Column Oven Temperature (± 5°C). The method was found to be linear over the concentration range 50-150 μg/ml with coefficient correlation r2 = 0.998. After developing method and studying validation parameter to obtain result complying with USP monograph. The proposed method can be useful in the routine analysis for the determination on Metformin HCl Floating tablet dosage.

Keywords: Metformin HCl in Floating dosage, Reverse phase HPLC, potassium dihydrogen phosphate, (K2H2PO4), 1- Octane Sulphonic acid sodium solt mili- Q water, Acetonitrile.