Simultaneous estimation of metformin hydrochloride, pioglitazone hydrochloride, and glimepiride by RP-HPLC in tablet formulation.
A simple, precise, rapid, and reproducible reversed-phase high-performance liquid chromatography method is developed for the simultaneous estimation of metformin hydrochloride (MET), pioglitazone hydrochloride (PIO), and glimepiride (GLP) present in multicomponent dosage forms. Chromatography is carried out isocratically at 25 degrees C +/- 0.5 degrees C on an Inertsil-ODS-3 (C-18) Column (250 x 4.60 mm, 5 microm) with a mobile phase composed of methanol-phosphate buffer (pH 4.3) in the ratio of 75:25 v/v at a flow rate of 1 mL/min. Detection is carried out using a UV-PDA detector at 258 nm. Parameters such as linearity, precision, accuracy, recovery, specificity, and ruggedness are studied as reported in the International Conference on Harmonization guidelines. The retention times for MET, PIO, and GLP are 2.66 + 0.5 min, 7.12 + 0.5 min, and 10.17 + 0.5 min, respectively. The linearity range and percentage recoveries for MET, PIO, and GLP are 10-5000, 10-150, and 1-10 microg/mL and 100.4%, 100.06%, and 100.2%, respectively. The correlation coefficients for all components are close to 1. The relative standard deviations for three replicate measurements in three concentrations of samples in tablets are always less than 2%.
Jain
Deepti
D
School of Pharmaceutical Sciences, Rajiv Gandhi Technical University, Pharmacy. deepti2515@yahoo.com
Jain
Surendra
S
Jain
Deepak
D
Amin
Maulik
M
D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D007004:Hypoglycemic Agents / Q000032:analysis*; D008687:Metformin / Q000032:analysis*; D000077205:Pioglitazone; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013453:Sulfonylurea Compounds / Q000032:analysis*; D013607:Tablets / Q000737:chemistry*; D045162:Thiazolidinediones / Q000032:analysis*
D007004:Hypoglycemic Agents; D013453:Sulfonylurea Compounds; D013607:Tablets; D045162:Thiazolidinediones; C057619:glimepiride; D008687:Metformin; D000077205:Pioglitazone