Original Articles
S. Ashutosh Kumar, Manidipa De
Abstract
The present work was undertaken with the aim to develop and validate a rapid and consistent RP-HPLC method in which the peaks will be appear with short period of time as per ICH guidelines. The HPLC separation was achieved on an XTerra C18 column in an Isocratic Mode. The mobile phase was composed of phosphate buffer (25 %) [pH 3.0 adjusted with OPA] and methanol (75 %) The flow rate was monitored at 1.0mL per min. The wavelength was selected for the detection was 254 nm. The retention time found for metformin, pioglitazone and glimepiride were 1.997, 3.238 and 4.042 min respectively. The % recovery was found 98.46- 101.79 for metformin, 98.04 - 101.79 for pioglitazone and 99.60 - 100.45 for glimepiride. The linearity was established in the range of 80-120 μg/mL for metformin and 2.4-3.6 μg/mL for pioglitazone and 0.16-0.24 μg/mL for glimepiride. The LOD for metformin, pioglitazone and glimepiride were 0.07, 0.07 and 0.006 μg/mL respectively. The LOQ for metformin, pioglitazone and glimepiride were 0.23, 0.24 and 0.02 μg/mL respectively. The proposed method was adequate sensitive, reproducible, and specific for the determination of metformin, pioglitazone and glimepiride in bulk samples as well as in tablet dosage form.