Abstract
A highly sensitive isocratic reverse phase high performance liquid chromatographic method was developed and validated for the estimation of Repaglinide and Metformin hydrochloride in Bulk drug and Pharmaceutical dosage forms. Separation of Repaglinide and Metformin hydrochloride successfully achieved on C18, 250×4.6mm,5μ SS column or equivalent utilizing Acetonitrile: phosphate buffer (58:42)v/v as mobile phase at a flow rate of 1mL/min and the eluates was monitored at 230 nm. Chromatogram showed peak at a retention time of 2.053 ± 1 min and 5.537 ± 1 min. The method was validated for system suitability, linearity, precision, accuracy, specificity, ruggedness, robustness, LOD and LOQ. Recovery of Repaglinide and Metformin hydrochloride were found to be in the range of 99.80% and 99.70% and showing linearity in the range of 0.1-0.6 μg / ml and 25-150 μg / ml. Proposed method can be successfully applied for the quantitative determination of Repaglinide and Metformin hydrochloride in Bulk drug and Pharmaceutical dosage form.
Issue
The Experiment 2012
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KeyWords:
Repaglinide, Metformin hydrochloride, RP-HPLC, validation, Acetonitrile, phosphate buffer