DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR SIMULTANEOUS ESTIMATION OF MIGLITOL AND METFORMIN HYDROCHLORIDE IN TABLET DOSAGE FORM.

A simple, rapid and precise stability indicating reverse phase high performance liquid chromatographic method has been developed for simultaneous estimation of Miglitol and Metformine Hydrochloride in their tablet dosage form. Chromatography was performed on a Phenomenex ODS C18 (250 X 4.6 mm) 5mm column using Water: Methanol (50:50, v/v) pH: 4 mixture as a mobile phase. The detection was carried out at 235 nm with a flow rate of 1.0 mL/min. The retention times were 4.807 and 3.273 minutes for Miglitol and Metformine Hydrochloride, respectively. The linearity of the method was excellent over a concentration range 2.5 to 7.5μg/mL for Miglitol and 25 to 75μg/mL for Metformine Hydrochloride. The correlation coefficient was 0.997 and 0.999 for Miglitol and Metformine Hydrochloride, respectively. The limit of detection was 0.6607μg/mL and 1.740μg/mL for Miglitol and Metformine Hydrochloride, respectively. The limit of quantitation was 2.0021μg/mL and 5.2736μg/mL for Miglitol and Metformine Hydrochloride, respectively. The relative standard deviation values for repeatability, intraday precision and interday precision studies were less than 2 % and % recovery was between 98 % to 102 % for both drugs.