Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF METFORMIN AND TELMISARTAN IN BULK AND PHARMACEUTICAL DOSAGE FORMS USING RP-HPLC METHOD.

P.Gayathri*, K.N.Jayaveera, Sasikiran Goud and N.Sravan Reddy.

ABSTRACT

The purpose of the present study is to develop a new, simple, rapid, accurate and precise RP-HPLC method for the simultaneous estimation of Metformin (Met) and Telmisartan (Tel) in bulk and in tablet formulations. The chromatographic separation was done by waters with BDS 250mm x 4.6 mm, 5 column and is maintained at 30oC temperature with mobile phase of Buffer: Acetonitrile: Methanol taken in the ratio 35:55:10, flow rate 1mL/min, injection volume 10μl and runtime maintained is of 8min. Buffer was prepared by weighing 2.72gm of potassium dihydrogen Ortho phosphate in a 1000mL volumetric flask and add 900mL of milli-Q water and sonicated for 10min to degas and finally make up the volume with water then pH adjusted to 4 with dil.Ortho phosphoric acid Solution. The retention time and mean recoveries for Met was obtained at 2.492 and 100.11, Tel was at 3.711 and 99.923. Linearity response was established over the concentration range of 62.5-375ppm for Met and 5-30ppm for Tel. The correlation coefficient for Met and Tel was 0.9990 and 0.9990 respectively. The correct information about the recovery studies was found by the accuracy of the proposed method and the results were validated as per ICH guidelines. This method can be used for the routine quality control of both drugs in combination in bulk and tablet dosage forms.

Keywords: Metformin, Telmisartan, RP-HPLC and validation.